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

Model Number G34323

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/26/2019

Event Type  malfunction  

Manufacturer Narrative

Initial reporter occupation: lead tech.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, during percutaneous transluminal angioplasty of the distal end of a venous bypass of the superficial femoral artery, involving a female patient in her "60s or 70's, the advance 18 lp low profile balloon catheter experienced a leak.Access was gained using a 5 fr cook sheath, and following the first inflation attempt using an unknown inflation device, a pinhole was noted after reaching 1 atm of pressure.Upon observing contrast "blooming" into the vessel, the physician deflated and removed the balloon, by itself, from the patient.Reportedly, the contrast used was a 50/50 contrast/saline ratio.The patient did not have much tortuosity or calcification, and "no unreasonable amount of angulation".However, the lesion was noted to contain 75% stenosis.According to the initial reporter, a competitor's device was used 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.

Manufacturer Narrative

Investigation evaluation: reviews of the complaint history, device history record, drawing, instructions for use (ifu), quality control procedure, and a visual inspection & functional test of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the balloon was in used condition with slight biological matter within the balloon.During the functional testing of the device, a pinhole in the balloon material near the proximal end of the balloon was noted.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, drawing, and quality control procedures were conducted, and no gaps were discovered.An ifu is also provided with this device, noting all the appropriate indications, contraindications, warnings, and precautions.There is no evidence to suggest the customer used the device in an incorrect manner.Based on the information provided and the examination of the returned product, the investigation does not point to a clear conclusion for the complaint event to have occurred.There was no evidence the complaint device was manufactured outside of current specifications or that the patient's diseased state contributed to the device failure.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Measures are being conducted to address this failure mode.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 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: 9134204
• MDR Text Key: 197608177
• Report Number: 1820334-2019-02446
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 10827002343235
• UDI-Public: (01)10827002343235(17)200323(10)7772248
• 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: 02/04/2020

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: 03/23/2020
• Device Model Number: G34323
• Device Catalogue Number: PTA4-18-150-4-2
• Device Lot Number: 7772248
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Initial Date Manufacturer Received: 09/26/2019
• Initial Date FDA Received: 09/30/2019
• Supplement Dates Manufacturer Received: 01/29/2020
• Supplement Dates FDA Received: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 5 FR COOK RAABE SHEATH