MAUDE Adverse Event Report: COOK INC ADVANCE MICRO ¿ 14 ULTRA LOW-PROFILE PTA BALLOON CATHETER; LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number PTA3-14-150-1.5-2

Device Problem Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/24/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.

Event Description

It was reported that during a tibial artery intervention, the advance micro ¿ 14 ultra low-profile pta balloon catheter hub cracked at the y-connector.The procedure was able to be successfully completed using another balloon catheter.A section of the device did not remain inside the patient¿s body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.One used advance micro 14 ultra low-profile pta balloon catheter was returned for evaluation.Leakage was detected at the hub.Abrasions are noted at 7.0 centimeters (cm), 7.5 cm, 9.5 cm, and 10.9 cm from the proximal end.A kink was noted at the proximal end where tubing meets strain relief.No non-conformities were noted at the strain relief.A small bump and hole are visible in the hub.Leakage was noted from the hole.The leakage from the hub occurred from a hole in the hub (the glue port).During the manufacturing process, the device is 100% low pressure leak checked during inspection and is high pressure leak tested.Per manufacturing instruction, "position the y-fitting such that the glue ports are directly upward.Insert adhesive into distal glue port.Insert adhesive into the proximal glue port.Be sure the adhesive is between the over fill and under fill lines and that glue port is filled.Slide catheter under the uv light source wand and activate uv light by pressing down the foot pedal." based on the information provided, examination of the returned product, and the results of our investigation, the root cause for this event was determined to be related to the manufacturing process.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• Brand Name: ADVANCE MICRO ¿ 14 ULTRA LOW-PROFILE PTA BALLOON CATHETER
• Type of Device: LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 7072415
• MDR Text Key: 94207366
• Report Number: 1820334-2017-04304
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122940
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PTA3-14-150-1.5-2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1