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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC ADVANCE 18 LP LOW PROFILE BALLOON CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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COOK INC ADVANCE 18 LP LOW PROFILE BALLOON CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number G30958
Device Problems Fluid Leak; Material Puncture / Hole
Event Date 04/10/2019
Event Type  Malfunction  
Manufacturer Narrative

Customer (person)= unknown. Occupation= unknown. Pma/510(k) number = k130293. Device evaluated by mfg = other (81) - device evaluation has begun; however, a conclusion is not yet available. This report includes information known at this time. A follow-up report will be submitted should additional relevant information become available.

 
Event Description

As initially reported, an advance 18 lp low profile balloon catheter was "defective". Upon receipt and investigation of the device, a pin hole leak was noted in the middle of the balloon when the device was inflated with water. Further details of the event are unknown. Additional information regarding event details, patient anatomy and outcome has been requested, but is not available at this time.

 
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Brand NameADVANCE 18 LP LOW PROFILE BALLOON CATHETER
Type of DeviceLIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington , IN 47404
8123392235
MDR Report Key8659635
Report Number1820334-2019-01362
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Type of Report Initial
Report Date 08/30/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/31/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberG30958
Device Catalogue NumberPTA4-18-150-5-20
Device LOT Number7930533
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/28/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/30/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/22/2017
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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