MAUDE Adverse Event Report: COOK INC ADVANCE 35 LP LOW PROFILE BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Catalog Number	PTA5-35-80-8-6.0
Medical Device Problem Codes	Material Rupture (1546); Human Factors Issue (2948)
Health Effect - Clinical Codes	Thrombosis (2100); No Code Available (3191)
Date of Event	03/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: manufacturer not specified: 5fr sheath; manufacturer not specified: 0.35 glidewire.(b)(4).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported the 8x60mm advance 35 lp low profile balloon catheter ruptured during a right upper extremity fistulagram procedure for angioplasty.The advance 35 lp low profile balloon catheter was advanced through a 5fr sheath over an 0.35 glide wire.The balloon was inflated 3 times without incident up to a max pressure of 18-20 atmospheres(atm).It was reported the physician was aware the rated burst pressure was 11 atm.The 4th and final time the balloon was inflated to 18atm it ruptured circumferentially, leaving three-quarters of the balloon and one radiopaque marker inside the fistula at the access site.Unspecified contrast was used at a 70/30 mix.Reportedly there was no vessel angulation or calcification.Of note, prior to the procedure, the physician noted that the fistula had thrombosed proximal to the access site; therefore, he decided to perform an open revision to remove the balloon material versus trying to remove it endovascularly.All of the balloon material including the band was removed without incident.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation a review of the complaint history, device history record, documentation, drawing, instructions for use (ifu), quality control, specifications, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the catheter shaft was returned separated into two segments.The balloon portion was returned separated into three segments, and the distal segment of the device exhibited accordion damage.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 be noted there were no other reported complaints for this lot number.The device is shipped with an ifu which states: warnings the balloon is manufactured from an extra-thinwall, high-strength, minimally-compliant material.Particular care should be taken in handling the balloon to prevent damage.It will inflate to the indicated size parameters when utilizing proper pressure recommendations.Adhere to balloon inflation pressure parameters indicated in the compliance card insert.Refer to label for further information.Based on the information provided, the examination of the returned product, and the results of our investigation, the root cause was determined to be related to the usage or handling of the device by the operator.We will continue to monitor for similar complaints.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.Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation.A review of the complaint history, device history record, documentation, drawing, instructions for use (ifu), quality control, specifications, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the catheter shaft was returned separated into two segments.The balloon portion was returned separated into three segments, and the distal segment of the device exhibited accordion damage.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 be noted there were no other reported complaints for this lot number.The device is shipped with an ifu which states: warnings the balloon is manufactured from an extra-thinwall, high-strength, minimally-compliant material.Particular care should be taken in handling the balloon to prevent damage.It will inflate to the indicated size parameters when utilizing proper pressure recommendations.Adhere to balloon inflation pressure parameters indicated in the compliance card insert.Refer to label for further information.Based on the information provided, the examination of the returned product, and the results of our investigation, the root cause was determined to be related to the usage or handling of the device by the operator.We will continue to monitor for similar complaints.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 35 LP LOW PROFILE BALLOON CATHETER
• Common Device Name: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7426829
• Report Number: 1820334-2018-00791
• Device Sequence Number: 1195696
• Product Code: DQY
• UDI-Device Identifier: 10827002523606
• UDI-Public: (01)10827002523606(17)191107(10)7420687
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K091527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: PTA5-35-80-8-6.0
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/14/2018
• Supplement Date Received by Manufacturer: 05/03/2018
• Initial Report FDA Received Date: 04/12/2018
• Supplement Report FDA Received Date: 05/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR