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

Catalog Number PTA4-18-150-5-20

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/12/2018

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) number: k130293.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, an (b)(6) male weighing (b)(6) was undergoing a left popliteal intervention procedure.On initial inflation, the advance 18 lp low profile balloon catheter developed a pinhole leak at the proximal end.The complaint device was inflated to 8 atmospheres (atm) with a mix of unspecified contrast to saline in a 4:10 ratio using a cook sphere inflation device.Length of inflation time was not known.There was no angulation but some calcification of the target vessel.The complaint device was removed and another device was used successfully to complete the procedure.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

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation evaluation.A review of the dimensional verification, complaint history, device history record, documentation, instructions for use (ifu), quality control, specifications, and a functional test & visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the balloon had biomatter both internally and externally.During the functional test, the device was inflated with air inside a break of water.Air bubbles emerged and confirm the presence of a pinhole leak.Upon further inspection, a dark area on the balloon material indicated where the hole was located.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.This nonconformance was for a damaged balloon.While this nonconformance is related to the reported failure, it should be noted that the affected unit was scrapped and not replaced prior to order completion.It should also be noted there were no other reported complaints for this lot number.Furthermore, a review of the quality control procedures was conducted, and no gaps were discovered.Moreover, an ifu is provided with the device, which states ¿that the intended use of the catheter is for percutaneous transluminal angioplasty of lesions in the peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral, and iliofemoral.¿ it goes on to say ¿to not exceed the rated burst pressure as rupture may occur.Upon removal from the packaging, the product is to be inspected for damage.¿ in addition, the ifu also mentions ¿a 1:1, saline to contrast mixture is directed to be used as the inflation medium.¿ based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be established.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: 8068905
• MDR Text Key: 128253338
• Report Number: 1820334-2018-03348
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 10827002309583
• UDI-Public: (01)10827002309583(17)210917(10)9167081
• 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: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/17/2021
• Device Catalogue Number: PTA4-18-150-5-20
• Device Lot Number: 9167081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2018
• Date Manufacturer Received: 11/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COOK 6FR ANSEL SHEATH, COOK HYDRO ST WIRE
• Patient Age: 79 YR
• Patient Weight: 84