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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. REDIGUARD IAB: 7FR 30CC SYSTEM, BALLOON, INTRA-AORTIC

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ARROW INTERNATIONAL INC. REDIGUARD IAB: 7FR 30CC SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAB-S730C
Device Problem Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/28/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the medical doctor had "difficulty inserting the balloon" the intra-aortic balloon (iab). There was no report of patient death, serious injury or complications.
 
Event Description
It was reported that the medical doctor had "difficulty inserting the balloon" the intra-aortic balloon (iab). There was no report of patient death, serious injury or complications.
 
Manufacturer Narrative
(b)(4). Teleflex did not receive the device for investigation. Therefore, the reported complaint of iab swg insertion difficulty 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: na.
 
Manufacturer Narrative
(b)(4). Teleflex did not receive the device for investigation. Therefore, the reported complaint of iab swg insertion difficulty 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 was reopened to investigate the device that was returned to teleflex for investigation. The reported complaint of iab tight over guidewire is confirmed. The returned iab central lumen was found kinked and resistance was noted upon loading the guidewire into the central lumen. The root cause of the kink 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 that the medical doctor had "difficulty inserting the balloon" the intra-aortic balloon (iab). There was no report of patient death, serious injury or complications.
 
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Brand NameREDIGUARD IAB: 7FR 30CC
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key7723478
MDR Text Key115137979
Report Number3010532612-2018-00226
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K981660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 06/28/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2019
Device Catalogue NumberIAB-S730C
Device Lot Number18F17D0016
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/29/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/07/2019
Is This a Reprocessed and Reused Single-Use Device? No

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