MAUDE Adverse Event Report: COOK INC ADVANCE 18 LP LOW PROFILE BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Model Number	G50267
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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, a female in her 70's underwent a lower extremity angiogram procedure in which the advance 18 lp low profile balloon catheter was used.An ansel sheath was advanced up and over the aortic bifurcation to the patients left common iliac artery (cia).Successful percutaneous transluminal angioplasty (pta) of the left external iliac artery (leia) was performed with both a cook advance 18 lp low profile balloon catheter 6x40mm balloon and another manufacturer's 7x40mm drug coated balloon (dcb).The physician attempted to angioplasty with the 8x40mm advance 18 lp low profile balloon catheter 80cm shaft and the balloon ruptured longitudinally once it reached 10 atmospheres (atm) for 10 seconds.Another advance 18 lp low profile balloon catheter 8x40mm balloon, 135cm shaft, was inserted and taken to 10atm for 2 min without complication.Additional information was received indicating a cook inflation device was used to inflate the complaint device.A mixture of 70% contrast to 30% normal saline solution was in use.Mild to moderate calcification was present in the treated artery.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.
Additional Manufacturer Narrative
A review of the complaint history, device history record, documentation, instructions for use (ifu), quality control, and a visual inspection and functional evaluation of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed the presence of a pinhole rupture of the balloon material.The pinhole leak on the balloon material was located a distance of 77.5 cm from the strain relief.No additional findings were noted.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, the root cause cannot be traced to the device.The conclusion of this investigation is that the balloon failed due to the surrounding calcification of the dilatation site.We will continue to monitor for similar complaints.Per the quality engineering 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.
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: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8044300
• Report Number: 1820334-2018-03305
• Device Sequence Number: 16440981
• Product Code: DQY
• UDI-Device Identifier: 10827002502670
• UDI-Public: (01)10827002502670(17)210611(10)8940818
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K073378
• 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): 01/17/2019

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 Expiration Date: 06/11/2021
• Device Model Number: G50267
• Device Catalogue Number: PTA4-18-80-8-4
• Device Lot Number: 8940818
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/29/2018
• Supplement Date Received by Manufacturer: 10/29/2018
• Initial Report FDA Received Date: 11/06/2018
• Supplement Report FDA Received Date: 01/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BARD LUTONIX DCB
• Patient Weight: 113