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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC ADVANCE 35 LP LOW PROFILE BALLOON CATHETER DQY CATHETER, PERCUTANEOUS

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COOK INC ADVANCE 35 LP LOW PROFILE BALLOON CATHETER DQY CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number PTA5-35-80-7-2.0
Device Problem Material Perforation (2205)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/17/2018
Event Type  Malfunction  
Manufacturer Narrative

Common name & product code: unavailable as the device lot number, rpn, and gpn are unknown. Pma/510(k) number: unavailable as the device lot number, rpn, and gpn are unknown. This report includes information known at this time. A follow-up report will be submitted should additional relevant information become available.

 
Event Description

It was reported, a patient was undergoing a planned procedure to dilate a severely calcified common iliac artery in the right leg which had been stented some years before, implant date and stent manufacturer unknown. Another manufacturer's introducer caught on the stent and an effort was made to re-modulate the stent using advance pta 5 balloon catheters, which perforated. These were easily removed from the patient's anatomy. Subsequently, a stent-in-stent procedure was performed. While post-dilating the stent with an advance 35 lp low profile balloon catheter. The balloon catheter ruptured circumferentially during the first inflation at 7 atmospheres just prior to reaching nominal pressure. Another manufacturer's inflation device was used for the inflation. Ultravist contrast and normal saline were used in a 1 to 1 ratio. While trying to remove the ruptured advance 35 lp low profile balloon catheter through another manufacturer's introducer the balloon tore at the top. An attempt was made to retrieve the torn piece through a second 8 french (fr) introducer using a snare device but this was not successful. The procedure was aborted at this point and the patient required surgery to completely remove the retained piece of the balloon. The surgery was successful and the patient was fine. The original procedure was rescheduled for another date. No further adverse effects have been reported. Additional information has been requested regarding the number of advance pta 5 balloon catheters which perforated and to ascertain the product and lot numbers. According to the company representative, no further information is available at this time. This report is for the perforated balloons and there was no adverse patient effect as a result of that event. The surgical procedure noted above was as a result of a separate advance pta balloon rupture. Please reference medwatch 1820334-2018-03500 which was submitted to capture the balloon rupture and tear as well as the piece of the balloon retained in the patient's anatomy and the aborted procedure.

 
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Brand NameADVANCE 35 LP LOW PROFILE BALLOON CATHETER
Type of DeviceDQY CATHETER, PERCUTANEOUS
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key8166511
MDR Text Key131141677
Report Number1820334-2018-03705
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
PMA/PMN NumberK091527
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/28/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/14/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberPTA5-35-80-7-2.0
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/02/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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