MAUDE Adverse Event Report: COOK INC ADVANCE 18 LP LOW PROFILE BALLOON CATHETER; LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number G30964

Device Problem Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/08/2019

Event Type  malfunction  

Manufacturer Narrative

Occupation = radiology tech.Pma/510(k) number = k130293.Device evaluated by mfg = device evaluation has begun; however, a conclusion is not yet available.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

As initially reported, during angioplasty of the right superficial femoral artery with post-dilation of a stent, advance 18 lp low profile balloon catheter would not inflate.A 6 french, 45 centimeter cook ansel sheath was used during the procedure as well as a cook inflation device.The user attempted to inflate the device with two milliliters of omnipaque contrast mixed with twelve milliliters of saline; however, the device would not inflate at all.The balloon was removed by itself and was not reinserted into the patient.Another device of the same type was used to successfully complete the procedure.The patient's anatomy was not tortuous or calcified.Upon return and initial examination of the device on 16oct2019, a pinhole leak was found on the balloon.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.

Manufacturer Narrative

Summary of event: as initially reported, during angioplasty of the right superficial femoral artery with post-dilation of a stent, advance 18 lp low profile balloon catheter would not inflate.A 6 french, 45 centimeter cook ansel sheath was used during the procedure as well as a cook inflation device.The user attempted to inflate the device with two milliliters of omnipaque contrast mixed with twelve milliliters of saline; however, the device would not inflate at all.The balloon was removed by itself and was not reinserted into the patient.Another device of the same type was used to successfully complete the procedure.The patient's anatomy was not tortuous or calcified.Upon return and initial examination of the device on 16oct2019, a pinhole leak was found on the balloon.Investigation evaluation: a review of the device history record, documentation, drawing, manufacturing instructions, quality control, and a visual inspection and functional test of the complaint device was conducted during the investigation.A visual inspection of the returned device confirmed the return of one used pta balloon catheter.Bio-matter was present and no visible damage to the catheter was noted.Balloon was inflated without difficulty and leaked from a pin hole.A document-based investigation evaluation was performed.No related non-conformances were found, and there have been no other reported complaints for this lot number.There is no evidence to support that the device was manufactured out of specification or to suggest items in the lot or similar devices in the field or in house are nonconforming.The instructions for use (ifu) for the device states the following: ¿do not exceed rated burst pressure.Rupture of balloon may occur.Adhere to balloon inflation pressure parameters in the compliance card insert.Over-inflation may cause rupture of the balloon, which resultant damage to the vessel wall.Use of a pressure gauge is recommended to monitor inflation pressures.Note: if resistance is met while advancing the balloon dilatation catheter, determine the cause and proceed with caution.Inflate balloon to desired pressure.If balloon pressure is lost and/or balloon rupture occurs, deflate balloon and remove balloon and sheath as a unit.Deflate the balloon by pulling vacuum on the inflation syringe or inflation device.Maintain vacuum on the balloon and withdraw the catheter.Upon catheter withdrawal, a gentle counterclockwise rotation of the catheter will assist balloon rewrap, minimizing trauma to the percutaneous entry site.If resistance is met during withdrawal, apply negative pressure with a larger syringe before proceeding.If resistance continues, remove balloon and sheath as a unit.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.Based on the information provided, examination of the returned product, and the results of the investigation, cook has concluded that a definitive root cause cannot be determined; however, the failure could be related to post-dilation of a stent.The risk assessment for this failure mode was reviewed, and no additional escalation actions are recommended or required.The appropriate personnel have been notified and cook will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, 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 18 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: 9329533
• MDR Text Key: 194202555
• Report Number: 1820334-2019-02897
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 10827002309644
• UDI-Public: (01)10827002309644(17)220809(10)9939229
• 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: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/09/2022
• Device Model Number: G30964
• Device Catalogue Number: PTA4-18-150-6-20
• Device Lot Number: 9939229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2019
• Date Manufacturer Received: 03/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR