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

Catalog Number	PTA4-18-150-6-20
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Pma/510(k) number: k130293.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported that during a percutaneous transluminal angioplasty (pta) of a calcified lesion in the superficial femoral artery (sfa), the advance 18 lp low profile balloon catheter was inflated to 8 atmospheres (atm) and burst longitudinally inside the patient's anatomy.Reportedly, the balloon would not deflate and the patient's anatomy was described as "tortuous".After successful removal over the wire guide, it was observed the balloon resembled a "long filament, or like a yarn".A section of the device did not remain inside the patient¿s anatomy nor were any additional procedures required.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the dimensional verification, complaint history, device history record, drawing, instructions for use (ifu), quality control, specifications, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the balloon had both longitudinal and radial ruptures.The radial rupture was a distance of 11.4 cm from the distal end of the device.The longitudinal rupture was 1.9 cm in length, and began a length of 9.5 cm from the distal end.Additionally, 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 are being conducted to address this failure mode.We will continue to monitor for similar complaints.Per the quality engineering risk assessment, no further action is required.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: ADVANCE 18 LP LOW PROFILE BALLOON CATHETER
• Common Device Name: LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7549383
• Report Number: 1820334-2018-01439
• Device Sequence Number: 1698575
• Product Code: LIT
• UDI-Device Identifier: 10827002309644
• UDI-Public: (01)10827002309644(17)210202(10)8557966
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: PTA4-18-150-6-20
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/14/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 05/29/2018
• Supplement Report FDA Received Date: 08/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1