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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 G52331
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Patient Involvement (2645)
Event Date 06/26/2020
Event Type  Malfunction  
Manufacturer Narrative

Occupation: director. 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, prior to use during an angiogram, the seal was noted to be missing from an advance 35 lp low profile balloon catheter package. As the user opened the package, the seal was noted to be missing and the balloon was missing from the shaft. The device did not make contact with any patient. A new device of the same type was used to complete the 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
jennifer canada
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key10233454
MDR Text Key197598143
Report Number1820334-2020-01255
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK091527
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation
Type of Report Initial
Report Date 07/06/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/06/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberG52331
Device Catalogue NumberPTA5-35-80-4-2.0
Device LOT Number9996240
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/26/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/06/2019
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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