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

Model Number G34359

Device Problem Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/17/2019

Event Type  malfunction  

Manufacturer Narrative

Occupation: unknown.Pma/510(k) number = 17184.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) female was undergoing angioplasty of the superficial femoral (sfa) and posterior tibial arteries.An advance 35 lp low profile balloon catheter was introduced over the 0.35 wire and positioned where required in the sfa.The balloon would not inflate during the procedure, never reaching 5 atmospheres (atm).Contrast was noted to be running out of the balloon at approximately 4 atm.A 50/50 mix of contrast to saline was used during the attempted inflation.The complaint balloon was removed over a cook wire and through a 5 fr cook sheath and a tiny hole was noted at one end.Blood was observed in the inflation device.The balloon was not inflated inside a stent.The patient's anatomy was noted to have "very slight tortuosity in the sfa" and stenosis, however calcification was not noted.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 Description

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

Manufacturer Narrative

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 pta5-35-80-5-20.0 was returned for investigation.There was biomatter present throughout the device.The device inflated with water and a pinhole rupture was noted at the proximal shoulder of the balloon.The device was then inflated with air inside a beaker filled with water to capture an image of the failure.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, specifications, and quality control procedures were conducted, and no gaps were discovered.Through these reviews, cook has confirmed that appropriate controls are in place to address this reported failure.Moreover, an ifu is provided with the device, which states that the device is intended ¿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 also states as a step for balloon introduction and inflation, " 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 a root cause for this event could not be established.There is no evidence to suggest the device was not manufactured to specification and not enough evidence to point to a likely cause.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.

• 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: 8570723
• MDR Text Key: 144172742
• Report Number: 1820334-2019-00942
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 10827002343594
• UDI-Public: (01)10827002343594(17)210409(10)8758979
• Combination Product (y/n): N
• 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: 06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/09/2021
• Device Model Number: G34359
• Device Catalogue Number: PTA5-35-80-5-20.0
• Device Lot Number: 8758979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2019
• Date Manufacturer Received: 06/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR