MAUDE Adverse Event Report: COOK INC ADVANCE 14 LP LOW PROFILE BALLOON CATHETER; LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number G50328

Device Problem Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2019

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) number: k170193.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

It was reported a patient of unknown gender or age was undergoing an intervention of a lesion in the anterior tibial artery.Two attempts were made to inflate the advance 14 lp low profile balloon catheter in the target vessel but the balloon would not remain inflated.A cook sheath, french size not provided, was utilized along with an unknown manufacturer's inflation device.The inflation medium and ratio were not provided.The complaint device was removed and flushed.A hole in the shaft of the balloon was noted.The procedure was successfully completed with another balloon.Information was not provided regarding the angulation, calcification, or tortuosity of the patient's vessel.Reportedly, the patient did not experience any adverse effects or require any additional procedures as a result of this occurrence.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation: reviews of the complaint history, device history record, drawing, instructions for use (ifu), manufacturer¿s instructions, quality control, specifications, and functional test & visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed that one ptax4-14-170-3-4 was returned for investigation.Biomatter was present throughout the device.There was no visible defects on the balloon.During the functional test, an attempt was made to inflate the balloon and a leak was noted in the catheter shaft approximately 47cm from the distal end of the strain relief.The catheter felt slightly rough to the touch at the area of the leak and there was slight surface damage noted using a camera with magnification.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 that this lot number did have one other complaint (pr231248) with the same failure mode.That being said, several searches and reviews of supplier lots and subassembly lots have been conducted and no nonconformances have been discovered.Furthermore, reviews of the manufacturer¿s instructions, drawing, quality control procedures, and the overall design history file were conducted, and no gaps were discovered.Moreover, an ifu is provided with the device, which states ¿do not exceed rated burst pressure.1 rupture of balloon may occur.Adhere to balloon inflation pressure parameters in the compliance card insert.Over-inflation may cause rupture of the balloon, with resultant damage to the vessel wall.Use of a pressure gauge is recommended to monitor inflation pressures." based on the information provided and the examination of the returned product, investigation has concluded that a root cause could not be established.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.

• Brand Name: ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
• Type of Device: LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8348435
• MDR Text Key: 136888631
• Report Number: 1820334-2019-00444
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 10827002503288
• UDI-Public: (01)10827002503288(17)210423(10)8792432
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/23/2021
• Device Model Number: G50328
• Device Catalogue Number: PTAX4-14-170-3-4
• Device Lot Number: 8792432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Date Manufacturer Received: 04/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1