MAUDE Adverse Event Report: COOK INC ADVANCE MICRO ¿ 14 ULTRA LOW-PROFILE PTA BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Catalog Number	PTA3-14-90-3-12
Medical Device Problem Codes	Hole In Material (1293); Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 an angiogram with runoff, two advance micro 14 ultra low-profile pta balloon catheters, from two separate lot numbers, ruptured during inflation in the popliteal artery.The first balloon catheter was inflated to 14 atmosphere (atm), and the second was inflated to 8 atm.Per the initial reporter, the corresponding inflation pressure of each lot is unknown.It was noted that heavy arterial calcification was present.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.It was initially reported that both devices were from the same lot; however, per additional information received on (b)(6) 2018, it was noted that the balloon catheter was from lot number 7363546 (refer to medwatch 1820334-2018-00185), and the other from lot number 7939515.Medwatch 1820334-2018-00378 documents the event for lot number 7939515.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.One used advance micro® 14 ultra low-profile pta balloon catheter (pta3-14-90-3-12) was returned for investigation.The visual inspection of the complaint device noted kinks were present at 4.0 cm, 21.2 cm, 32.5 cm, 56.3 cm, and 60.1 cm from the proximal end.Additionally, a pinhole leak was noted at 7.0 cm from the distal end of catheter.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.Numerous design verification and validation activities have been performed to ensure that this device meets design requirements.Based on the information provided, examination of the returned product, and the results of our investigation, the most likely root cause of the failure of this device was patient anatomy caused a pinhole leak in the balloon.Heavy calcification was reported to be present, which has the potential to damage the balloon catheter.Per the [quality engineering] risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.

• Brand Name: ADVANCE MICRO ¿ 14 ULTRA LOW-PROFILE PTA BALLOON CATHETER
• Common Device Name: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7247515
• Report Number: 1820334-2018-00378
• Device Sequence Number: 13719668
• Product Code: DQY
• UDI-Device Identifier: 10827002266107
• UDI-Public: (01)10827002266107(17)200524(10)7939515
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K122940
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2018

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: PTA3-14-90-3-12
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/31/2018
• Supplement Date Received by Manufacturer: 05/29/2018
• Initial Report FDA Received Date: 02/07/2018
• Supplement Report FDA Received Date: 06/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1