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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC ADVANCE MICRO ¿ 14 ULTRA LOW-PROFILE PTA BALLOON CATHETER DQY CATHETER, PERCUTANEOUS

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COOK INC ADVANCE MICRO ¿ 14 ULTRA LOW-PROFILE PTA BALLOON CATHETER DQY CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number PTA3-14-150-2-12
Device Problems Stretched (1601); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/27/2015
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

The complainant reported a cross-over pta (percutaneous transluminal angioplasty) in the crural vessels. Another manufacturer's wire guide was stuck inside the advance micro 14 ultra low-profile pta balloon catheter during recanalization of the crural vessels. It was further noted that the wire guide remained inside the balloon catheter, and a portion of the catheter felt stretched. There were no reported serious injuries to the patient as a result of the product problem.

 
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Brand NameADVANCE MICRO ¿ 14 ULTRA LOW-PROFILE PTA BALLOON CATHETER
Type of DeviceDQY CATHETER, PERCUTANEOUS
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8128294891
MDR Report Key7591460
MDR Text Key111446194
Report Number1820334-2018-01792
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeNL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 06/12/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/12/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberPTA3-14-150-2-12
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/06/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/18/2014
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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