MAUDE Adverse Event Report: COOK, INC. ADVANCE 35 LP LOW PROFILE BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Catalog Number PTA5-35-80-7-4.0

Device Problem Material Separation (1562)

Patient Problem Foreign body, removal of (2365)

Event Date 04/13/2015

Event Type  Injury  

Event Description

A pelvic angiogram was being performed on an (b)(6) male patient, who had heavily calcified iliacs and a history of vascular disease.A.035" 7 x 40 x 80 balloon was advanced over the wire and inflated to nominal pressure.The balloon perforated and was withdrawn off the wire.At this time, they noticed the balloon was completely torn and the balloon catheter tip was inside the patient on the wire as they could see the marker.Artery forceps were used to try and remove the wire and catheter.At this stage, the catheter broke in half again.Artery forceps were then used to remove the rest of the product.No adverse effects to the patient were reported due to this occurrences.

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Manufacturer Narrative

One advance 35 lp low profile balloon catheter was returned for investigation.Also returned was one wire guide one introducer and one balloon catheter from another manufacturer.A review of the complaint history, documentation, drawing, review of instructions for use (ifu), manufacturing instructions (mi), quality control (qc), specifications, and a visual inspection was conducted during the investigation.An examination of the returned products revealed that the introducer had another manufacturers balloon catheter through it, a wire guide with part of the 35 lp catheter on it, and a hemostat clamping a separated piece of the advance 35 lp balloon catheter.A visual examination of the device noted the balloon was separated in two halves circumferentially.The distal section of the balloon was turned inside out and measured approximately 1.4 cm from the mold line.The proximal section of the balloon measured approximately 2 5 cm from the mold line.It appears no material is missing from the balloon.A section of the catheter that would be inside the balloon was on the wire guide.There were teeth marks on the catheter where it was removed from the body.This section measured approximately 4.9 cm there was also a section of catheter attached to the distal balloon piece.This section of catheter measured approximately 4 8 cm.It appears that there was significant stretching of the catheter inside of the balloon based on the measurement and appearance of these two sections.Per qc specification, quality control personnel 100 percent verify the balloon catheter does not leak.Each device is shipped with an instructions for use (ifu) that describes the intended use, warnings and precautions.Per dfmea balloon burst, compliance, and fatigue verification testing have been performed.The balloon is designed to burst longitudinally which minimizes the risk of balloon and/or catheter separation upon device withdrawal.Based on the information provided and the results of our investigation, a definitive root cause cannot be determined.However, as mentioned in the description of event, the patient's vessels were heavily calcified; which may have contributed to the circumferential burst.We have notified the appropriate personnel and will continue to monitor this device.Per the quality engineering risk assessment (qera), no further action will be taken at this time.

• Brand Name: ADVANCE 35 LP LOW PROFILE BALLOON CATHETER
• Type of Device: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: larry pool, manager ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4730750
• MDR Text Key: 15321089
• Report Number: 1820334-2015-00257
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 10827002523521
• UDI-Public: (01)10827002523521(17)170601(10)5022918
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K091527
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor,distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2017
• Device Catalogue Number: PTA5-35-80-7-4.0
• Device Lot Number: 5022918
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/14/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/13/2015
• Device Age: 10 MO
• Event Location: Hospital
• Date Manufacturer Received: 12/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 80