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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 LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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COOK INC ADVANCE 35 LP LOW PROFILE BALLOON CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number G35532
Device Problems Balloon (419); Hole In Material (1293); No Pressure (2994)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/10/2017
Event Type  Malfunction  
Manufacturer Narrative

This mdr is being filed after the associated complaint was reviewed under remediation protocol_(b)(4), compliant/mdr retrospective review and remediation and reassessed as reportable. Additional complaint investigation and record remediation was not performed.

 
Event Description

When attempting to inflate the balloon it would not hold pressure. When the balloon was observed a pinhole was noted in the balloon. No adverse event were reported.

 
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Brand NameADVANCE 35 LP LOW PROFILE BALLOON CATHETER
Type of DeviceLIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8128294891
MDR Report Key6707095
MDR Text Key80027754
Report Number1820334-2017-01889
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 07/12/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/12/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberG35532
Device Catalogue NumberPTA5-35-135-5-20.0
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/28/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/06/2016
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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