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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
Catalog Number PTA5-35-135-6-20.0
Device Problem Material Rupture (1546)
Patient Problem No Code Available (3191)
Event Date 01/05/2018
Event Type  Injury  
Manufacturer Narrative
Additional information received on 27feb2018: the ruptured balloon catheter was an advance 35 lp low profile balloon catheter (lot 8017024). This report includes information known at this time.  a follow-up report will be submitted should additional relevant information become available.
 
Manufacturer Narrative
Investigation ¿ evaluation: a review of the dimensional verification, complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, and a visual inspection of the returned device were conducted during the investigation. The visual inspection of the returned device confirmed that the balloon ruptured circumferentially 30 mm from the distal tip. There were three kinks in the catheter, which were 80 mm, 84 mm, and 95 mm from the distal tip of the device. Additionally, a document based investigation evaluation was performed. There is no evidence to suggest the product was not made to specifications. A review of the device history record showed no nonconforming events which could contribute to this failure mode. It should be noted there were no other reported complaints for this lot number. Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined. Measures have been conducted to address this failure mode. We will continue to monitor for similar complaints. Per the risk assessment, no further action is required. This report is required by the fda under 21 cfr part 803. This report is based on unconfirmed information submitted by others. Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
 
Manufacturer Narrative
Common name & product code
=
unavailable as the device lot number, rpn, and gpn are unknown. Pma/510(k) number
=
unavailable as the device lot number, rpn, and gpn are unknown. (b)(4). This report includes information known at this time.  a follow-up report will be submitted should additional relevant information become available.
 
Event Description
It was reported that during an unspecified procedure, a cook medical balloon catheter ruptured. The patient's tissue was cut down in order to retrieve the ruptured balloon. 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. Additional information regarding event details and patient anatomy has been requested, but is not available at this time.
 
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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
MDR Report Key7213753
MDR Text Key285186042
Report Number1820334-2018-00125
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
PMA/PMN Number
K132020
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup,Followup
Report Date 03/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberPTA5-35-135-6-20.0
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/27/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 01/23/2018 Patient Sequence Number: 1
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