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

Model Number G30958

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/10/2019

Event Type  malfunction  

Manufacturer Narrative

Customer (person)= unknown.Occupation= unknown.Pma/510(k) number = k130293.Device evaluated by mfg = other (81) - 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, an advance 18 lp low profile balloon catheter was "defective".Upon receipt and investigation of the device, a pin hole leak was noted in the middle of the balloon when the device was inflated with water.Further details of the event are unknown.Additional information regarding event details, patient anatomy and outcome has been requested, but is not available at this time.

Event Description

Additional information received, please see h10.

Manufacturer Narrative

H10: additional information was reported following the submission of the previous medwatch report.As reported, during a lower extremity angiogram performed on a patient with no vessel calcification, a cook advance 18 lp low profile balloon catheter burst while in the patient.The balloon burst on initial inflation of 8 atm, which lasted less than two minutes.The target lesion was described as having 70-80% occlusion, with no angulation or vessel tortuosity proximal to the target lesion.The balloon was not inflated inside a stent when it ruptured.Following the rupture, the balloon was removed alone.It is unknown how the procedure was completed, and no information regarding patient outcome has been reported.Investigation/evaluation: reviews of the complaint history, device history record, drawing, quality control procedures, and instructions for use (ifu) and a visual inspection, dimensional verification, and functional test of the returned device were conducted during the investigation.The visual inspection of the returned device revealed biomatter present, indicative of use within a patient.The rewrapping tool was noted on the catheter shaft.No externally-facing flaws were found.Functional testing, however, revealed a pinhole rupture toward the center of the balloon material.No further deficiencies were found on the device.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 one nonconforming event which could contribute to this failure mode.However, the affected unit was scrapped and not replaced prior to order distribution.It should be noted there were no other reported complaints for this lot number.Furthermore, reviews of the drawing and quality control procedures were conducted, and no gaps were discovered.The device is accompanied with instructions for use (ifu).The ifu outlines the intended use of the device as being designed 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 includes warnings against exceeding the rated burst pressure and to use an inflation device equipped with a pressure gauge to monitor the inflation pressures.Based on the information provided and the examination of the returned product, investigation has concluded that no cause can be established for the device failure.Measures are being conducted to address this failure mode.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 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: 8659635
• MDR Text Key: 147482165
• Report Number: 1820334-2019-01362
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 10827002309583
• UDI-Public: (01)10827002309583(17)200522(10)7930533
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/22/2020
• Device Model Number: G30958
• Device Catalogue Number: PTA4-18-150-5-20
• Device Lot Number: 7930533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2019
• Initial Date Manufacturer Received: 05/31/2019
• Initial Date FDA Received: 05/31/2019
• Supplement Dates Manufacturer Received: 08/30/2019
• Supplement Dates FDA Received: 08/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1