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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC SYSTEM, BALLOON, INTRA-AORTIC

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ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAB-05840-LWS
Device Problem Connection Problem (2900)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/10/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported the event occurred in the (b)(6) lab, during use on a patient. The fiber optic sensor (fos) adaptor could not be connected to the pump. Several attempts to connect the catheter to the pump by means of the blue fos adaptor has failed. Hospital staff tried to use more force to be able to connect the fos adaptor to the pump, but to no success. As a result, a new intra-aortic balloon (iab) catheter set was open and used successfully. There was no report of patient complication or serious injury and death.
 
Manufacturer Narrative
(b)(4). Teleflex did not receive the device for investigation therefore the reported complaint of fos connection problem is not able to be confirmed. The root cause of the complaint is undetermined. A device history record (dhr) review was conducted for the lot number with no relevant findings. The device passed all manufacturing specifications prior to release. The reported complaint will be monitored for any developing trends. If the product is returned at a later date, a full investigation of the sample will be completed. No further action required at this time.
 
Event Description
It was reported the event occurred in the cath lab, during use on a patient. The fiber optic sensor (fos) adaptor could not be connected to the pump. Several attempts to connect the catheter to the pump by means of the blue fos adaptor has failed. Hospital staff tried to use more force to be able to connect the fos adaptor to the pump, but to no success. As a result, a new intra-aortic balloon (iab) catheter set was open and used successfully. There was no report of patient complication or serious injury and death.
 
Manufacturer Narrative
(b)(4). Teleflex did not receive the device for investigation therefore the reported complaint of fos connection problem is not able to be confirmed. The root cause of the complaint is undetermined. A device history record (dhr) review was conducted for the lot number with no relevant findings. The device passed all manufacturing specifications prior to release. The reported complaint will be monitored for any developing trends. If the product is returned at a later date, a full investigation of the sample will be completed. No further action required at this time. Other remarks: this complaint has been reopened to investigate the device that has been returned to teleflex for investigation. The reported complaint of the iab fos connection problem is confirmed. The fos was returned with a recessed connector and the fiber was broken; therefore, a light path could not be established between the sensor and the pump. The root cause of the recessed fos and broken fiber is undetermined. A device history record (dhr) review was conducted for the lot number with no relevant findings. The device passed all manufacturing specifications prior to release. Teleflex assessed the risk for the reported complaint. There are no new or revised risks. This will be monitored for any developing trends. No further action required at this time.
 
Event Description
It was reported the event occurred in the cath lab, during use on a patient. The fiber optic sensor (fos) adaptor could not be connected to the pump. Several attempts to connect the catheter to the pump by means of the blue fos adaptor has failed. Hospital staff tried to use more force to be able to connect the fos adaptor to the pump, but to no success. As a result, a new intra-aortic balloon (iab) catheter set was open and used successfully. There was no report of patient complication or serious injury and death.
 
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Brand NameFIBEROPTIX ULTRA 8 IAB: 8FR 40CC
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
16 elizabeth drive
chelmsford MA 01824
Manufacturer Contact
carmen sherman
16 elizabeth drive
chelmsford, MA 01824
9782505100
MDR Report Key7411557
MDR Text Key104890623
Report Number3010532612-2018-00073
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K021462
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2019
Device Catalogue NumberIAB-05840-LWS
Device Lot Number18F17H0009
Other Device ID Number00801902007247
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/29/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/03/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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