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U.S. Department of Health and Human Services

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

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COOK INC ADVANCE 18 LP LOW PROFILE PTA BALLOON DILATATION CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number N/A
Device Problems Balloon rupture; Material Rupture
Event Date 12/05/2014
Event Type  Injury  
Event Description

Upon ballooning, the balloon ruptured on the plaque and broke off into multiple pieces. Pieces had to be snared out. Imaging did not show any remaining pieces.

 
Manufacturer Narrative

(b)(4). The event is currently under investigation.

 
Manufacturer Narrative

(b)(4). Investigation a review of complaint history, instructions for use (ifu), quality control, trends, and a visual inspection of the returned device were conducted during the investigation. One balloon catheter was returned for investigation. A visual examination of the device noted the balloon ruptured circumferentially. The tip material broke off the catheter and the balloon was broken into 3 pieces. The ifu, states under the warnings heading, ¿do not exceed rated burst pressure. Rupture of balloon may occur. Adhere to balloon inflation pressure parameters in the compliance card insert. Over-inflation may cause rupture of the balloon, with resultant damage to the vessel wall. Use of a pressure gauge is recommended to monitor inflation pressures. Do not use a power injector for balloon inflation. Rupture may occur. ¿ the balloon is designed to burst longitudinally which minimizes the risk of balloon and/or catheter separation upon devices withdrawal. Detection activities have been conducted; the reason for this failure cannot be determined. We will notify the appropriate internal personnel and continue to monitor for similar complaints.

 
Event Description

Upon ballooning, the balloon ruptured on the plaque and broke off into multiple pieces. Pieces had to be snared out. Imaging did not show any remaining pieces.

 
Manufacturer Narrative

(b)(4).

 
Event Description

Upon ballooning, the balloon ruptured on the plaque and broke off into multiple pieces. Pieces had to be snared out. Imaging did not show any remaining pieces.

 
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Brand NameADVANCE 18 LP LOW PROFILE PTA BALLOON DILATATION 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 Key4377103
Report Number1820334-2015-00006
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 12/05/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/22/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/06/2017
Device MODEL NumberN/A
Device Catalogue NumberPTAX4-18-170-6-10
Device LOT Number5335974
OTHER Device ID NumberN/A
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/11/2014
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/05/2014
Device Age2 mo
Event Location Hospital
Date Manufacturer Received12/05/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/06/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/22/2014 Patient Sequence Number: 1
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