MAUDE Adverse Event Report: COOK INC ADVANCE 14 LP LOW PROFILE BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Catalog Number	PTAX4-14-170-4-8
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/20/2018
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.(b)(4); mw5078023_recvd 02-jul-2018.
Event or Problem Description
An fda sus report (mw5078023) was received 07/02/2018 reporting an advance 14 lp low profile balloon catheter broke inside the sheath upon removal from a patient.During follow up, the complainant reported the complaint device was being used to treat a complete occlusion of the superficial femoral artery (sfa) with access gained via the pedal route.Initially the balloon portion of the complaint device was inflated to treat the lesion in the sfa and worked "flawlessly".The second insertion of the complaint device was performed without difficulty; however, upon removal, some resistance was encountered.The tip of the balloon could not be removed through the 4 french (fr) sheath.It separated from the shaft of the complaint device.The 4fr sheath was removed over the wire with the balloon portion still in the sheath.A new 4fr sheath was placed and the procedure was continued as planned.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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
A review of the complaint history, device history record, documentation, 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 catheter was separated into two segments.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 one nonconforming event which could contribute to this failure mode; however, the device was identified and scrapped during manufacturing.Based on the information provided, the examination of the returned product, and the results of our investigation, the root cause was traced to the user.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.

• Brand Name: ADVANCE 14 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: 7691270
• Report Number: 1820334-2018-02130
• Device Sequence Number: 2581018
• Product Code: DQY
• UDI-Device Identifier: 10827002503370
• UDI-Public: (01)10827002503370(17)210308(10)8652236
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K090822
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2018

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 Expiration Date: 03/08/2021
• Device Catalogue Number: PTAX4-14-170-4-8
• Device Lot Number: 8652236
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/02/2018
• Supplement Date Received by Manufacturer: 10/16/2018
• Initial Report FDA Received Date: 07/16/2018
• Supplement Report FDA Received Date: 11/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1