MAUDE Adverse Event Report: COOK INC ADVANCE MICRO ¿ 14 ULTRA LOW-PROFILE PTA BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Model Number G26677

Device Problem Material Perforation (2205)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/14/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Pma/510(k) number: pre-amendment.This report includes information known at this time.A follow-up report will be submitted at the conclusion of the investigation or, when additional relevant information becomes available.

Event Description

It was reported, a (b)(6) year old female patient underwent an angioplasty of the right lower limb using an advance micro 14 ultra low-profile pta balloon catheter.The balloon was passed until it reached the injury.It was then observed through fluoroscopy that it did not inflate.The complaint balloon was removed and a perforation was seen at the distal end of the balloon.Another balloon 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

Reviews of the complaint history, device history record, instructions for use (ifu), quality control, and a visual inspection of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, multiple images of the removed device were provided.All images show a used balloon catheter outside the body.Although several of the images were blurry, image 4 clearly shows the distal end of the balloon catheter.The green catheter and blue distal tip are characteristics of the complaint device.The balloon appeared inflated and contained red matter towards the distal tip.This supports the customer¿s claim of a distal balloon perforation as it would allow biomatter to be taken in when pulling negative pressure on the balloon.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 two nonconforming events which could potentially contribute to this failure mode.One nonconformance was for balloon material folded incorrectly.The second was related to leakage found during a high pressure testing of the device.Though these nonconformances may be related to the reported failure, it should be noted that all affected units were 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 this device, which states prior to inserting the device, the balloon is to be prepped, including a vacuum pulled.It goes on to include steps if balloon pressure is lost and/or a balloon rupture occurs.After removing the device from its packaging, it is to be inspected to ensure no damage occurred after being packaged.Based on the information provided and no product returned, investigation has concluded that a root cause for this event can 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

Additional information was received on 11jun2019 noting that the cook sheath was used in this procedure along with an unknown "insufflator".The device was inflated one time in the anterior tibial artery for 30 seconds, but would not inflate over 2 atmospheres of pressure.A one part henetix contrast was used with a two part saline solution to inflate the balloon.When removing the balloon out by itself, a perforation was noted at the distal end of the balloon.Reportedly, there was no angulation, tortuosity, or calcification.Another balloon was used to complete the procedure.There was no blood noted in the inflation device and the balloon was not inflated inside the stent prior to rupture.

• Brand Name: ADVANCE MICRO ¿ 14 ULTRA LOW-PROFILE PTA BALLOON CATHETER
• Type of Device: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8677228
• MDR Text Key: 147622837
• Report Number: 1820334-2019-01294
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 10827002266770
• UDI-Public: (01)10827002266770(17)201006(10)8273187
• Combination Product (y/n): N
• PMA/PMN Number: K122940
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/06/2020
• Device Model Number: G26677
• Device Catalogue Number: PTA3-14-150-2.5-8
• Device Lot Number: 8273187
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 50 YR