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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 LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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COOK INC ADVANCE MICRO ¿ 14 ULTRA LOW-PROFILE PTA BALLOON CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number PTA3-14-150-1.5-2
Device Problem Crack
Event Date 11/24/2017
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). The event is currently under investigation. A supplemental report will be provided upon conclusion.

 
Event Description

It was reported that during a tibial artery intervention, the advance micro ¿ 14 ultra low-profile pta balloon catheter hub cracked at the y-connector. The procedure was able to be successfully completed using another balloon catheter. A section of the device did not remain inside the patient¿s body. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

 
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Brand NameADVANCE MICRO ¿ 14 ULTRA LOW-PROFILE PTA 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
8123392235
MDR Report Key7072415
Report Number1820334-2017-04304
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation
Type of Report Initial
Report Date 02/23/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/30/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberPTA3-14-150-1.5-2
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 Received02/09/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/07/2017
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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