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

Model Number	N/A
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported that during an aortic iliac bifurcation procedure using an advance 35 lp low profile balloon catheter, the balloon ripped.The patient's anatomy was severely calcified.The physician went up with the balloon and the balloon ripped in half while coming back down.The physician was able to retrieve the parts of the catheter but not the balloon.A stent was placed to cover the balloon material that could not be retrieved.Per the physician, everything looked good after the procedure and as of the next morning the patient was doing really well.The inflation pressure was requested but not yet provided.The type of contrast that was used was isoview and the mix of contrast to saline was a 50/50 ratio.The patient's lesion was located in the right iliac with some angulation.Vessel calcification was severe.Additionally, it was reported that the balloon did not burst but instead, it ripped circumferentially.The patient did not require any additional procedures due to this occurrence.There were no reports of adverse effects on the patient due to this occurrence.
Additional Manufacturer Narrative
Additional information: retrieved fractured catheter pieces with snare.Investigation - evaluation: a review of the complaint history, dimensional verification, device history record, instructions for use (ifu), manufacturing instructions, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.One used advance 35 lp low profile balloon catheter was returned for investigation.The pta 5 balloon was returned ruptured longitudinally and radially.Inspection of the device noted that the marker band tubing inside of the balloon was separated from the shaft and was 5.9cm in length.Marker bands were not present.The returned balloon was 2.6cm in length.Total length of the balloon catheter was 131.9 cm.Both measurements are out of specification.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.According to the ifu, "the pta5-35-135-8-4.0 balloon is manufactured from an extra-thin wall, high-strength, minimally-compliant material.Particular care should be taken in handling the balloon to prevent damage.¿ the patient had heavy calcification as well as angulation and the customer stated the balloon ¿ripped¿ and did not rupture.Based on the available information it is reasonable to suggest that technique, procedure or human anatomy contributed to the balloon tear.A definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• 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: 6707359
• Report Number: 1820334-2017-01660
• Device Sequence Number: 1853065
• Product Code: DQY
• UDI-Device Identifier: 10827002522791
• UDI-Public: (01)10827002522791(17)191209(10)7504514
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2017

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 Model Number: N/A
• Device Catalogue Number: PTA5-35-135-8-4.0
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/19/2017
• Supplement Date Received by Manufacturer: 10/12/2017
• Initial Report FDA Received Date: 07/12/2017
• Supplement Report FDA Received Date: 10/26/2017
• 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: 74 YR
• Patient Weight: 61