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

Model Number	N/A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).The event is currently under investigation.
Event or Problem Description
During a pta (percutaneous transluminal angioplasty) procedure to treat the bk (below knee) eccentric cto (chronic total occlusion) in the sfa (superior femoral artery).The device was advanced from the right groin over a 0.035" wire guide and inflated.However, the balloon ruptured at nominal pressure.Then, it was changed with another manufacturer's device and the procedure was completed successfully.There have been no adverse effects to the patient reported.
Additional Manufacturer Narrative
Investigation - evaluation : a review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, trends and quality control was conducted during the investigation.The device is shipped with an instruction for use (ifu) that describes the intended use; specific items are addressed such as: device description: "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.Use only the recommended balloon inflation medium.Never use air or any gaseous medium to inflate the balloon.If balloon pressure is lost and/or balloon rupture occurs, deflate balloon and remove balloon and sheath as a unit." warnings: "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.Do not use a power injector for balloon inflation or injection of contrast medium through catheter lumen marked ¿distal¿.Rupture may occur." precautions: "use only the recommended balloon inflation medium.Never use air or any gaseous medium to inflate the balloon." the advance 35 lp low profile balloon catheter was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, no product returned and the results of the investigation, a definitive root cause could not be determined.The patient reportedly had a history of eccentric chronic total occlusion (cto) and infectious disease which may have contributed to the reported event.We will continue to monitor for similar complaints.Per the risk assessment no further action is required.

• 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: 6232614
• Report Number: 1820334-2017-00080
• Device Sequence Number: 19201694
• Product Code: DQY
• UDI-Device Identifier: 10827002523330
• UDI-Public: (01)10827002523330(17)170811(10)5198390
• Combination Product (Y/N): N
• PMA/510(K) Number: K091527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2017

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: PTA5-35-80-4-8.0
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/09/2017
• Supplement Report FDA Received Date: 06/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1