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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
Model Number G52362
Device Problems Material Rupture (1546); Material Separation (1562)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 05/30/2021
Event Type  Injury  
Manufacturer Narrative

It is unknown if the device will be returned. (b)(6). This report includes information known at this time. A follow-up report will be submitted should additional relevant information become available.

 
Event Description

As reported, during a fistuloplasty, an advance 35 lp low profile balloon catheter ruptured and separated. The distal fragment separated from the shaft of the device after the balloon ruptured. Everything was removed from the patient and the procedure continued. It is unknown how the separated portion of the device was retrieved. "some" distress and blood loss was reported as well as increased use of radiation. Additional information regarding the event has been requested.

 
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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
jason crouch
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key12072989
MDR Text Key264107961
Report Number1820334-2021-01613
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 08/24/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/27/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberG52362
Device Catalogue NumberPTA5-35-80-8-10.0
Device LOT Number13049890
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 Received08/23/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/13/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/27/2021 Patient Sequence Number: 1
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