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	10/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
An advance 35 lp low profile balloon catheter was used in a fistula case in the arm, it was very stenotic.There was no vessel calcification, but there was a previously placed stent in the vessel near the area where the balloon was being placed.It was reported that the balloon ruptured upon inflation with nominal pressure.They used 50% saline and 50% contrast.Another manufacturer's balloon was opened and used to complete the procedure.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.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, device history record, documentation, drawing, instructions for use (ifu), specifications, and quality control data and visual inspection of the returned device was conducted during the investigation.One advance 35 lp low profile balloon catheter was returned for evaluation.Inspection of the device noted no damage to the catheter shaft.The balloon was not able to be inflated due to leakage.It was noted the balloon had burst longitudinally and the rupture was 4.5cm in length.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.No information was provided regarding inflation rate or pressure.The instructions for use (ifu) note the following, "adhere to balloon inflation pressure parameters indicated in the compliance card insert.Refer to label for further information.Use of a pressure gauge is recommended to monitor inflation pressures." the complainant indicated that the vessel was stenotic and that there was a stent near the vessel area that may have contributed to the damage.The ifu notes the following, "choose a balloon appropriate to lesion length and vessel diameter" and "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." no information was provided regarding other products used during the procedure (e.G.Wire guide or sheath).Based on the information provided and evaluation of the returned product, the root cause is determined to be human anatomy related/other device related.Per the quality engineering risk assessment, no further risk reduction activities will be pursued at this time.We will notify the appropriate personnel and 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: 6937559
• Report Number: 1820334-2017-03552
• Device Sequence Number: 16264350
• Product Code: DQY
• UDI-Device Identifier: 10827002523408
• UDI-Public: (01)10827002523408(17)180924(10)6231522
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2017

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: PTA5-35-80-5-8.0
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/05/2017
• Supplement Date Received by Manufacturer: 11/03/2017
• Initial Report FDA Received Date: 10/10/2017
• Supplement Report FDA Received Date: 11/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1