MAUDE Adverse Event Report: COOK INC ADVANCE 14 LP LOW PROFILE BALLOON CATHETER; LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number G50321

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/05/2019

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, or unavailable.Pma/510(k) number = k170193.Precautions in the instructions for use (ifu) state air should never be used to inflate the advance 14 lp low profile balloon catheter.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

It was reported, during percutaneous transluminal angioplasty of the leg, "air wouldn't go into the balloon".It was said air was leaking out between the hub and catheter of the advance 14 lp low profile balloon catheter.Clarification has been requested for this report.Additionally it was reported patient demographics are unknown.The patient's anatomy was calcified.The complaint device was inflated with an unspecified mixture of contrast to saline using an unknown inflation device.The procedure was completed using another advance 14 lp low profile balloon catheter.The patient did not experience any adverse effects and the procedure was successfully completed.

Event Description

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

Manufacturer Narrative

Investigation ¿ evaluation: reviews of the complaint history, device history record, documentation, instructions for use (ifu), manufacturer¿s instructions, quality control procedures, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that no biological matter was noted.The balloon itself appeared to have been manipulated from the initial folding process and contained a clear liquid and substance of some sort.This information suggested that the device was prepped with a contrast medium, as originally reported.A syringe was connected to the balloon lumen and the plunger compressed to clear the device.There was no difficulty when applying pressure; however, leakage was confirmed between the hub and strain relief connection.Upon further inspection, a fracture was noted to run circumferentially around the hub.This separation was easily made visible by the adhesive used to reconnect the device which was also clearly separated along the same line.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 and quality control procedures were conducted, and no gaps were discovered.Moreover, an ifu is provided with this device, which states the ¿intended use outlines that it 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.¿ it is also noted in bold that particular care should be taken in handling the balloon to prevent damage.Additionally, upon removal from package the catheter is to be inspected to ensure no damage has occurred during shipping.Based on the information provided and the examination of the returned product, investigation has concluded a root cause for this event could not be established.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.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 14 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: 8440733
• MDR Text Key: 139573964
• Report Number: 1820334-2019-00557
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 10827002503219
• UDI-Public: (01)10827002503219(17)190712(10)NS7115851
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/12/2019
• Device Model Number: G50321
• Device Catalogue Number: PTAX4-14-170-2.5-4
• Device Lot Number: NS7115851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2019
• Date Manufacturer Received: 07/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1