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

Model Number G50317

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/23/2019

Event Type  malfunction  

Manufacturer Narrative

Occupation = unknown.Pma/510(k) number = k170193.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 a right lower limb peripheral angioplasty, the advance 14 lp low profile balloon catheter experienced a leakage.During the procedure a liquid contrast of 3ml by 7ml saline was used.The balloon was properly inserted through a 6fr cook sheath with the tip being guided to the lesion in the anterior tibial artery without any difficulty.Two attempts were made to inflate the balloon using an unknown inflation device for "about" two minutes; however, the balloon did not inflate and instead of holding, the pressure gauge was falling slowly.Upon removing the device from the patient, a leak from the proximal end of the balloon was noted.Reportedly, the lesion did not contain any angulation, tortuosity, or calcification; however, it was noted to have been "about 60%" occluded, with several points of occlusion in the segment being treated.Despite the incident, the distal recanalization procedure was successfully completed.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

Investigation/evaluation: reviews of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturer¿s instructions, quality control procedures, specifications, and a visual inspection of the device were conducted during the investigation.The complaint device was not returned; however, photos were provided by the customer.Upon examination of the photos provided, it was suspected that there was a leak in the balloon catheter shaft which caused the balloon not to inflate.The balloon material itself did not appear to be captured in the provided photos.There were no other devices of the same lot or sub-assembly lot within cook¿s control to be used for review, nor have there been any complaints with a similar enough event to be used as a representative device for the device failure analysis.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 did reveal two non-conformances that could potentially relate to the reported failure.For both non-conformances, units were scrapped and not replaced.It should also be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufacturer¿s instructions, drawing, specifications, and quality control procedures were conducted, and no gaps were discovered.Moreover, an ifu is provided with the device which states the device¿s intended use, preparation, and overall operation.Based on the information provided and no product returned, investigation has concluded that 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.

Event Description

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

• 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: 9130828
• MDR Text Key: 176457950
• Report Number: 1820334-2019-02440
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 10827002503172
• UDI-Public: (01)10827002503172(17)210623(10)NS8973682
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 11/21/2019

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: 06/23/2021
• Device Model Number: G50317
• Device Catalogue Number: PTAX4-14-170-2-12
• Device Lot Number: NS8973682
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/25/2019
• Initial Date FDA Received: 09/27/2019
• Supplement Dates Manufacturer Received: 11/19/2019
• Supplement Dates FDA Received: 11/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: KCFW-6.0-35-55-RB-HFANL1-HC
• Patient Age: 82 YR