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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD LINEAR 7.5 FR. 34CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE FAIRFIELD LINEAR 7.5 FR. 34CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Catalog Number 0684-00-0474
Device Problems Difficult to Insert (1316); Failure to Advance (2524)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/28/2017
Event Type  malfunction  
Manufacturer Narrative
Distributor: (b)(4). Device evaluation: the iab was returned with the membrane unfolded. No blood was visible on the catheter. The sheath was not returned for evaluation. An aneurysm was observed in the middle of the membrane. This may occur if the membrane is over inflated. A laboratory insertion test was unable to be performed due to the membrane being unfurled. An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected. A leak may impact the ability to maintain vacuum. We are unable to confirm the reported difficulty during insertion because of the returned condition of the catheter and we are unable to mimic the clinical setting. An evaluation of the product was unable to duplicate the reported problem. The product performed according to specification. A device and lot history record review was completed for the reported product. No non-conformances were found that are considered to be related to the event. Complaint # (b)(4).
 
Event Description
During a coronary intervention procedure, patient was in heart shock, so intra-aortic balloon (iab) therapy was initiated. The physician opened brand-new iab catheter, and started insertion. However, after insertion about 10cm from the distal tip, the iab catheter was unable to advance and the physician tried his best but could not insert. He decided to withdraw the iab catheter. The physician saw an usual shape / mark on the iab. Due to the urgent treatment to patient, doctor decided to open another iab catheter and he smoothly inserted and continue treatment for patient successfully. There was no reported injury to the patient.
 
Manufacturer Narrative
The product has been returned to the manufacturer, but is pending investigation. Once the investigation is completed a supplemental report with our findings will be submitted. (b)(4).
 
Event Description
During a coronary intervention procedure, patient was in heart shock, so intra-aortic balloon (iab) therapy was initiated. The physician opened brand-new iab catheter, and started insertion. However, after insertion about 10cm from the distal tip, the iab catheter was unable to advance and the physician tried his best but could not insert. He decided to withdraw the iab catheter. The physician saw an usual shape / mark on the iab. Due to the urgent treatment to patient, doctor decided to open another iab catheter and he smoothly inserted and continue treatment for patient successfully. There was no reported injury to the patient.
 
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Brand NameLINEAR 7.5 FR. 34CC IAB
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer (Section G)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer Contact
15 law drive
fairfield, NJ 07004
MDR Report Key7144797
MDR Text Key252104651
Report Number2248146-2017-00730
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K041281
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/02/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/11/2020
Device Catalogue Number0684-00-0474
Device Lot Number3000056310
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/21/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received01/10/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/11/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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