MAUDE Adverse Event Report: COOK INC ADVANCE 35 LP LOW PROFILE BALLOON CATHETER; LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number G35536

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/17/2019

Event Type  malfunction  

Manufacturer Narrative

This report includes information known at this time.A follow-up report will be submitted at the conclusion of the investigation or, when additional relevant information becomes available.

Event Description

It was reported, a (b)(6) year old male patient with a history of coronary artery disease, diabetes (type unspecified) and hypertension, underwent an unknown procedure in which the advance 35 lp low profile balloon catheter was used.It was noted that the patient had plaque and calcium build up in the superficial femoral artery (sfa).The lesion was located in the distal sfa.,which was seventy per cent occluded.There were no issues gaining access in the groin.At approximately mid to distal sfa, the initial inflation of the balloon inside a stent was taken up to 15 atmospheres (atm).The balloon started to leak and blood backed up into the inflation device due to a hole in the balloon.The physician removed the device intact without a sheath and used another balloon to complete the procedure.Nothing detached in the patient.No tortuosity or angulation was present in the patient's vessel.Optiray contrast in a 50/50 ratio to saline was used to inflate the balloon.No additional procedures were required.The patient did not experience any adverse effect.

Manufacturer Narrative

Investigation - evaluation.Reviews of the complaint history, device history record, drawing, instructions for use (ifu), manufacturer¿s instructions, quality control, specifications, and a functional test & visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed that one pta5-35-135-6-20.0 device was returned for investigation with biomatter present inside and on the balloon.The balloon was inflated with water and a pinhole leak was noted approximately 12.5cm from the proximal balloon bond.The balloon was then inflated with air inside of a water filled beaker in order to photograph the pinhole leak.This ability to recreate the failure mode confirmed the customer¿s complaint.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 also be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufacturer¿s instructions, drawings, and quality control procedures were conducted, and no gaps were discovered.Through these reviews, cook has confirmed that appropriate measures are in place to address this failure mode prior to distribution.Moreover, an ifu is provided with this device, which states the intended use of this device is, "for percutaneous transluminal angioplasty (pta) of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral, and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae." the ifu goes on to say, ¿if balloon pressure is lost and/or balloon rupture occurs, deflate balloon and remove balloon and sheath as a unit." based on the information provided and the examination of the returned product, investigation has concluded that this event cannot be traced to the device, but to the patient¿s condition.Reportedly, the patient¿s vessel was 70 percent occluded.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Measures are being conducted to address this failure mode.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 Description

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

• Brand Name: ADVANCE 35 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: 8639936
• MDR Text Key: 146059774
• Report Number: 1820334-2019-01257
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 10827002355368
• UDI-Public: (01)10827002355368(17)220201(10)9490830
• Combination Product (y/n): N
• PMA/PMN Number: K132020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2022
• Device Model Number: G35536
• Device Catalogue Number: PTA5-35-135-6-20.0
• Device Lot Number: 9490830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• Date Manufacturer Received: 07/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR