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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CREGANNA MEDICAL ALSO D/B/A CREGANNA-TACTX MEDICAL EMPIRA NC RX PTCA POST-DILATATION CATHETER PTCA CATHETER

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CREGANNA MEDICAL ALSO D/B/A CREGANNA-TACTX MEDICAL EMPIRA NC RX PTCA POST-DILATATION CATHETER PTCA CATHETER Back to Search Results
Model Number 75R10375N
Device Problems Deflation Problem (1149); Difficult to Remove (1528)
Patient Problems ST Segment Elevation (2059); Cardiac Tamponade (2226)
Event Date 08/29/2016
Event Type  malfunction  
Event Description
The patient was diagnosed as the left proximal anterior descending artery 99% stenosis. After implanted stent, under the normal pressure and expand the balloon. After inflated balloon found cannot pump back the contrast agent, unable to withdraw the balloon. The patient has st segment elevation, acute heart attack symptoms. The doctor withdrawn the catheter and guide wire and balloon catheter immediately, then the patient was symptom remission and safe. Then the surgeon advance the catheter and guidewire again, after angiographic observation, the stent was no obvious deformation. And replace with other brand balloon to expand and completed the procedure.
 
Manufacturer Narrative
As of 27 september 2016, when the complaint analysis was completed, the following additional information was received; the implanted stent was not a cordis product. There was not any problem reported with the implanted stent. The reported deflation difficulty occurred after the first inflation. 18 atmospheres were used to inflate the balloon catheter. There was difficulty removing the product from the hoop and it was very difficult to remove the protective balloon cover. The device was prepared normally (i. E. Maintain negative pressure). Henrui was used as contrast media, with contrast to saline ratio 1:1. There was no resistance/friction while inserting the balloon through the rotating hemostatic valve and there was no resistance/friction while inserting the balloon through the guide catheter. There was no difficulty advancing the balloon catheter through the vessel and crossing the lesion. The catheter was not in an acute bend. Product analysis review: product was not returned for review at the time of this report being completed. The device is not available for investigation and examination. It was therefore not possible to carry out any dimensional, functional, visual or microscopic examination on the device. Therefore the as reported classification of system - balloon deflation difficulty cannot be confirmed. A review of risk management documentation: based on a review of the risk documentation and information available, no updates are required to the risk documentation for the empira device. There is no indication of a potential processing or design failure associated with this complaint. A review of the manufacturing documentation: there was not any capa, (corrective and preventative action), mrr (material review report) or deviation being generated for this lot, ce1005474 during the manufacturing process that may have contributed to the reported issue. Statement on trend data (lot only): as of 27 september 2016, when the review was completed, there was no other complaint associated with lot number ce1005474, for the as reported failure empira - balloon - deflation difficulty. Was it used per ifu? in the achieved additional information was stated that there was difficulty removing the product from the hoop and it was very difficult to remove the protective balloon cover. The ifu section viii, 10, states: 'do not use the product if greater than normal resistance is met during the removal of the shipping stylet and/or balloon cover from the product. ', so the device was not used per the directions for use/product label. As reported / as analysed classification: the complaint reported has been assigned a primary as reported classification of empira - balloon - deflation difficulty following completion of creganna medical information review, the primary as analysed classification has been assigned empira - product not returned - complaint unable to confirm and the secondary as analysed classification has been assigned empira - n/a. The most probable root cause with rationale: product was not returned for review at the time of this report being completed. The device is not available for investigation and examination. It was therefore not possible to carry out any dimensional, functional, visual or microscopic examination on the device. Therefore the as reported classification of system - balloon deflation difficulty cannot be confirmed. In the achieved additional information was stated that there was difficulty removing the product from the hoop and it was very difficult to remove the protective balloon cover. The ifu section viii, 10, states: 'do not use the product if greater than normal resistance is met during the removal of the shipping stylet and/or balloon cover from the product. ', so the device was not used per the directions for use/product label. The probable root-cause classification code assigned to this complaint is 'user/use error'. The definition of 'user/use error' is defined as any complaint where was 'confirmed through complaint investigation that there was an act or omission of an act that resulted in a different medical device response than intended by the manufacturer or expected by the user. ' if further escalation is required: based on the above conclusion, no further escalation or corrective action is required at this time. We will continue to monitor for these complaint types.
 
Event Description
The patient was diagnosed as the left proximal anterior descending artery 99% stenosis. After implanted stent, under the normal pressure and expand the balloon. After inflated balloon found cannot pump back the contrast agent, unable to withdraw the balloon. The patient has st segment elevation, acute heart attack symptoms. The doctor withdrawn the catheter and guide wire and balloon catheter immediately, then the patient was symptom remission and safe. Then the surgeon advance the catheter and guidewire again, after angiographic observation, the stent was no obvious deformation. And replace with other brand balloon to expand and completed the procedure. Patient weight: (b)(6). Patient gender: male. Patient age at time of event: (b)(6).
 
Manufacturer Narrative
As of 11 october 2016, when the complaint analysis was completed, the following additional information was received; the implanted stent was not a cordis product. There was not any problem reported with the implanted stent. The reported deflation difficulty occurred after the first inflation. Eighteen (18) atmospheres were used to inflate the balloon catheter. There was difficulty removing the product from the hoop and it was very difficult to remove the protective balloon cover. The device was prepared normally (i. E. Maintain negative pressure). Henrui was used as contrast media, with contrast to saline ratio 1:1. There was no resistance/friction while inserting the balloon through the rotating hemostatic valve and there was no resistance/friction while inserting the balloon through the guide catheter. There was no difficulty advancing the balloon catheter through the vessel and crossing the lesion. The catheter was not in an acute bend. Product analysis review: the observations made during the analysis found the following: the balloon cover was not returned with the product. The stylet was not present when the product was returned for investigation. There were no kinks observed on the catheter. There was evidence the balloon had been prepared and inflated. There was some damage noted on the distal tip. Necking damage was noted, just proximal of the balloon on the distal shaft. Based on the investigation conducted the complaint (empira - balloon - deflation difficulty) could be confirmed. The noted necking damage just proximal of the balloon (distal shaft) will block the airflow to and from the balloon, so this damage does correspond with balloon - deflation difficulty. A review of risk management documentation: based on a review of the risk documentation and information available, no updates are required to the risk documentation for the empira device. There is no indication of a potential processing or design failure associated with this complaint. A review of the manufacturing documentation: there was not any capa, (corrective and preventative action), mrr (material review report) or deviation being generated for this lot, ce1005474 during the manufacturing process that may have contributed to the reported issue. Statement on trend data (lot only): as of 27 september 2016, when the review was completed, there was no other complaint associated with lot number ce1005474, for the as reported failure empira - balloon - deflation difficulty. Was it used per ifu? in the achieved additional information was stated that there was difficulty removing the product from the hoop and it was very difficult to remove the protective balloon cover. The ifu section viii, 10, states: 'do not use the product if greater than normal resistance is met during the removal of the shipping stylet and/or balloon cover from the product. ', so the device was not used per the directions for use/product label. As reported / as analysed classification: the complaint reported has been assigned a primary as reported classification of empira - balloon - deflation difficulty following completion of creganna medical information review, the primary as analysed classification has been assigned empira - distal shaft - damage and the secondary as analysed classification has been assigned empira - tip - damage. The most probable root cause with rationale: based on the investigation conducted the complaint (empira - balloon - deflation difficulty) could be confirmed. The noted necking damage just proximal of the balloon (distal shaft) will block the airflow to and from the balloon, so this damage does correspond with balloon - deflation difficulty. In the achieved additional information was stated that there was difficulty removing the product from the hoop and it was very difficult to remove the protective balloon cover. The ifu section viii, 10, states: [?]do not use the product if greater than normal resistance is met during the removal of the shipping stylet and/or balloon cover from the product. ', so the device was not used per the directions for use/product label. The probable root-cause classification code assigned to this complaint is [?]user/use error'. The definition of [?]user/use error' is defined as any complaint where was [?]confirmed through complaint investigation that there was an act or omission of an act that resulted in a different medical device response than intended by the manufacturer or expected by the user. ' if further escalation is required: based on the above conclusion, no further escalation or corrective action is required at this time. We will continue to monitor for these complaint types.
 
Event Description
The patient was diagnosed as the left proximal anterior descending artery 99% stenosis. After implanted stent, under the normal pressure and expand the balloon. After inflated balloon found cannot pump back the contrast agent, unable to withdraw the balloon. The patient has st segment elevation, acute heart attack symptoms. The doctor withdrawn the catheter and guide wire and balloon catheter immediately, then the patient was symptom remission and safe. Then the surgeon advance the catheter and guidewire again, after angiographic observation, the stent was no obvious deformation. And replace with other brand balloon to expand and completed the procedure. (b)(6).
 
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Brand NameEMPIRA NC RX PTCA POST-DILATATION CATHETER
Type of DevicePTCA CATHETER
Manufacturer (Section D)
CREGANNA MEDICAL ALSO D/B/A CREGANNA-TACTX MEDICAL
1353 dell ave
campbell
ca 95008 95008
Manufacturer (Section G)
CREGANNA MEDICAL ALSO D/B/A CREGANNA-TACTX MEDICAL
1353 dell ave
campbell
ca 95008
Manufacturer Contact
orla hickey
1353 dell ave
california
ca 95008 
0035391757
MDR Report Key5928722
MDR Text Key53934186
Report Number3004036480-2016-00003
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K110133
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/04/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/06/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2018
Device Model Number75R10375N
Device Catalogue NumberSA0457-37510
Device Lot NumberCE1005474
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/07/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/04/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/17/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 09/06/2016 Patient Sequence Number: 1
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