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

Catalog Number	PTAX4-14-170-3-8
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/24/2018
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, the shaft of the advance 14 lp low profile balloon catheter broke during a tibial artery percutaneous transluminal angioplasty (pta).Per the physician, there was no problem with the device's hydrophilic coating.It was activated using saline soaked gauze prior to the procedure.It is unclear if a competitor's balloon catheter was used or if the issue was noted after the completion of the procedure; however, the procedure was completed successfully without any adverse effect to the patient.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable.Or unchanged.Correction/additional information d10: on the initial report, this field was marked 'yes'; however, the product received by field was inadvertently left black, this date (07/31/2018) has been added.Investigation - evaluation a review of the dimensional verification, complaint history, device history record, 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.The separation site was frayed with 2mm of wires exiting the distal end of the proximal segment.The proximal segment was 148.6cm in length, the distal was 16.8cm in length, for a total of 165.4cm, which is within specification.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.Furthermore, during the device failure analysis, it was noted that a.014 wire would advance through the distal segment and the proximal segment.However, it stops at the distal end of the proximal segment where the damage has occurred.Gray markings were also noted on the distal end of the balloon.Moreover, an ifu is provided with the device that states "completely deflate the balloon using an inflation device or syringe.Allow adequate time for the balloon to deflate.If resistance is met during withdrawal, apply negative pressure with a larger syringe before proceeding.If resistance continues, remove balloon and sheath as a unit." it is not known if vacuum (using a syringe) was maintained during the attempt to withdraw the catheter.It does not appear that the balloon and sheath were removed as a unit until after the separation.It goes on to say, "if resistance continues, remove balloon and sheath as a unit." there is no information surrounding the sheath used in this procedure and if the sheath met its manufacturing quality specifications.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause can be traced to user technique.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 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: 7758833
• Report Number: 1820334-2018-02315
• Device Sequence Number: 11082699
• Product Code: DQY
• UDI-Device Identifier: 10827002503301
• UDI-Public: (01)10827002503301(17)210205(10)8562322
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K090822
• 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): 10/31/2018

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: 02/05/2021
• Device Catalogue Number: PTAX4-14-170-3-8
• Device Lot Number: 8562322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• Initial Date Received by Manufacturer: 07/24/2018
• Supplement Date Received by Manufacturer: 10/19/2018
• Initial Report FDA Received Date: 08/07/2018
• Supplement Report FDA Received Date: 10/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1