MAUDE Adverse Event Report: COOK INC ADVANCE 14 LP LOW PROFILE BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Catalog Number	PTAX4-14-110-2.5-12
Medical Device Problem Codes	Leak/Splash (1354); Material Rupture (1546); Device Operational Issue (2914)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 that during an angioplasty, the advance 14 lp low profile balloon catheter deflated at around 11 atmosphere (atm) and could not hold pressure.The catheter ruptured prior to reaching 12 atm; the balloon itself did not rupture.No optimal immediate result could be achieved as the stenosis was only able to be dilated at 10 atm.During inspection following the procedure, the balloon was observed to not be damaged; however, a leak at the level of the catheter was noted.It was noted that this was the first time this event had occurred in the past few weeks (second incident medwatch 1820334-2018-00204, third incident medwatch 1820334-2018-00205).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.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, and quality control was conducted during the investigation.The complaint device was not returned; therefore no physical examination could be performed.However, 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.The manufacturing processes in place at the time of manufacture were reviewed and it was found that the balloon material, distal, and proximal joints are quality control checked 100% for foreign matter and surface defects.Inflation/deflation verification testing, balloon minimum burst strength verification testing, and balloon fatigue verification testing was performed on the balloons.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 two other reported complaints for this lot number (created for the second and third occurrence of this event referred to in the initial report).Per the ifu, "upon removal from package, inspect the catheter to ensure no damage has occurred during shipping.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 recommendation.Do not exceed rated burst pressure.Rupture of balloon may occur.Over-inflation may cause rupture of the balloon, with resultant damage to the vessel wall.Use of a pressure gauge is recommended to monitor inflation pressures.Choose a balloon appropriate to lesion length and vessel diameter.If balloon pressure is lost and/or balloon rupture occurs, deflate balloon and remove balloon and sheath as a unit.Upon catheter withdrawal, a gentle counterclockwise rotation of the catheter will assist balloon rewrap, minimizing resistance through the sheath.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." based on the information provided, no product returned, and the results of our investigation, a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is required.The appropriate personnel have been notified, and monitoring will continue to be performed for similar complaints.

• Brand Name: ADVANCE 14 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: 7222849
• Report Number: 1820334-2018-00203
• Device Sequence Number: 14048055
• Product Code: DQY
• UDI-Device Identifier: 10827002187990
• UDI-Public: (01)10827002187990(17)201016(10)8295456
• Combination Product (Y/N): N
• PMA/510(K) Number: K090822
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2018

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: PTAX4-14-110-2.5-12
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/19/2018
• Supplement Date Received by Manufacturer: 03/12/2018
• Initial Report FDA Received Date: 01/26/2018
• Supplement Report FDA Received Date: 03/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1