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

Model Number G34319

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/15/2019

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, a patient of unknown age and gender underwent a below the knee leg procedure utilizing an advance 18 low profile balloon catheter.The patient's anatomy was not angled, calcified or tortuous.During the initial inflation of the balloon, contrast started leaking out.The balloon was removed through the sheath and another of the same was used to complete the procedure.A cook six french sheath and a cook inflation device were also used during the procedure along with isovue contrast in a 50/50 ratio with saline.The patient did not experience any adverse effects, no additional procedures were required and nothing had to be retrieved from the patient.

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.Additional information: investigation - evaluation.A review of the complaint history, drawings, device history record, instructions for use (ifu), manufacturing instructions, specifications, quality control, visual and functional inspection of the returned device was conducted during the investigation.One pta4-18-150-3-4 was returned for investigation.Biomatter was present throughout the device.No visible damage was noted on the device, balloon or catheter.An attempt was made to inflate the device with air and water using a 20cc syringe and cook inflation device, however the device would not inflate.It appears as if the inflation lumen is occluded with biomatter, not allowing the device to inflate.Attempts were made to draw negative pressure, however the occlusion could not be dislodged.There is no evidence to suggest that the device was not manufactured to specification.The device is shipped with instruction for use (ifu) which notes as steps for balloon introduction and inflation, "3.Under fluoroscopy, advance the balloon to the lesion site.Carefully position the balloon across the lesion using both the distal and proximal radiopaque balloon markers.Note: if resistance is met while advancing the balloon dilation catheter, determine the cause and proceed with caution.4.Inflate balloon to desired pressure.Adhere to recommended balloon inflation pressures.(see compliance card insert.) 5.If balloon pressure is lost and/or balloon rupture occurs, deflate balloon and remove balloon and sheath as a unit." 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 devices were scrapped.It should be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufactures instructions and quality control procedures were conducted, and no gaps were discovered.Based on the information provided and the examination of the returned product, investigation has concluded the cause of this event cannot be traced to the device.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 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, 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: 8457348
• MDR Text Key: 140165655
• Report Number: 1820334-2019-00697
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 10827002343198
• UDI-Public: (01)10827002343198(17)210215(10)8589648
• 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: 05/14/2019

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: 02/15/2021
• Device Model Number: G34319
• Device Catalogue Number: PTA4-18-150-3-4
• Device Lot Number: 8589648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2019
• Initial Date Manufacturer Received: 03/15/2019
• Initial Date FDA Received: 03/27/2019
• Supplement Dates Manufacturer Received: 05/02/2019
• Supplement Dates FDA Received: 05/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1