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

Catalog Number	PTA5-35-80-5-2.0
Medical Device Problem Codes	Kinked (1339); Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
It was reported that during an angioplasty for a superficial femoral artery (sfa) lesion, the balloon of the advance 35 lp low profile balloon catheter ruptured at 10 atmosphere (atm).A cook medical 180 centimeter guide wire and another manufacturer's 5 fr gauge sheath were used during the angioplasty.The balloon catheter was deflated, and partially retrieved using an anaconda snare over the 180 centimeter guide wire being utilized.Fluoroscopy was used to visualize the remaining tip of the delivery catheter and top half of the ruptured balloon, which were then able to be successfully removed from the patient's vessel using the anaconda snare.Removal was noted to be difficult, and snaring resulted in a kink at the tip of the detached catheter shaft.The patient's vessels were heavily calcified; however, the customer noted that the calcification had not caused any issues previously during the procedure.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
It was originally reported following the investigation of the device that the methods used during the procedure may have contributed to the malfunctioning of the device; however, it was later determined during a follow up review that the methods used did not contribute to the failure mode.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), specifications, quality control, functional testing, and visual inspection of the returned device was conducted during the investigation.One used, and one unused advance 35 lp low profile balloon catheter (lot 7639510) were returned for evaluation.The used device was returned with the catheter and the balloon separated.The distal and proximal bonds of the used device were intact.The balloon burst radially.The proximal section of the balloon measured 7 millimeters (mm).The distal section of the balloon measured 14 mm.The unused device was measured and confirmed to be within specifications.A burst test was performed and the unused device met the acceptance criterion.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Numerous design verification and validation activities have been performed to ensure that this device meets design requirements.Review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.Per the ifu, ¿the 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.Upon catheter withdrawal, a gentle counterclockwise rotation of the catheter will assist balloon rewrap, minimizing trauma to the percutaneous site.If resistance is met during withdrawal, apply negative pressure with a larger syringe before proceeding.If resistance continues, remove balloon and sheath as a unit.¿ the urografin contrast utilized during the event was neat, and therefore not diluted with saline.Per the ifu, ¿prepare balloon lumen with standard contrast-saline mixture as follows: fill a syringe of appropriate size with 1:1 mixture of contrast medium and normal saline." based on the information provided, examination of the returned product, and the results of our investigation, the balloon ruptured due to the use of undiluted contrast or potentially as result of the patient's calcified anatomy, which then lead to the catheter separation during extraction of the device.A quality engineering risk assessment was conducted to assess the risk of this failure mode.Appropriate measures have been initiated to address this failure mode.The appropriate internal personnel have been notified and we will continue to monitor 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: 7072560
• Report Number: 1820334-2017-04254
• Device Sequence Number: 1798192
• Product Code: DQY
• UDI-Device Identifier: 10827002523378
• UDI-Public: (01)10827002523378(17)200201(10)7639510
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K091527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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: PTA5-35-80-5-2.0
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/20/2017
• Supplement Date Received by Manufacturer: 02/21/2018; 05/02/2018
• Initial Report FDA Received Date: 11/30/2017
• Supplement Report FDA Received Date: 02/22/2018; 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