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

Catalog Number	PTAX4-14-170-2.5-20
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/05/2018
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 that during angioplasty of the left anterior tibial vessel, an advance 14 lp low profile balloon catheter would not hold pressure and was observed to be leaking.Access was gained using left pedal access, and the device was inflated to 7 atmosphere (atm) using omnipaque 350 contrast (50/50) when it was noticed that it would not maintain pressure.The device was removed from the body and examined.It was reported that the user observed a "pinhole" leak where the catheter and balloon meet.Another balloon of the same size was used to complete the procedure.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
Blank fields on this form indicate the information is unknown, or unavailable.Concomitant medical product received on: 11dec2018.Investigation ¿ evaluation.A review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, and specifications of the device, as well as a visual inspection and functional test, were conducted during the investigation.The visual and functional inspection of the complaint device concluded the balloon was unable to maintain pressure and a pinhole leak was visualized.The pinhole was noted near the proximal balloon bond.Catheter shaft near the pinhole was also noted to be kinked and flimsy.Because there was no indication that the balloon catheter was difficult to maneuver, this catheter surface damage is not believed to have been present upon initial usage of the device.Additionally, a document-based investigation evaluation was performed for product lot number 9189958 was reviewed and found to be accurate and complete.There was no nonconformances noted or listed in the record.Based on the information provided and the results of the investigation, a definitive cause could not be established.Per the quality engineering risk assessment, no further action is required.Cook will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, 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: 8152132
• Report Number: 1820334-2018-03704
• Device Sequence Number: 19220700
• Product Code: DQY
• UDI-Device Identifier: 10827002503264
• UDI-Public: (01)10827002503264(17)210926(10)9189958
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2019

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: 09/26/2021
• Device Catalogue Number: PTAX4-14-170-2.5-20
• Device Lot Number: 9189958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Initial Date Received by Manufacturer: 12/05/2018
• Supplement Date Received by Manufacturer: 03/08/2019
• Initial Report FDA Received Date: 12/11/2018
• Supplement Report FDA Received Date: 03/12/2019
• 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: 4FR COOK RADIAL SHEATH
• Patient Age: 64 YR