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	07/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A supplemental report will be submitted upon completion.
Event or Problem Description
It was reported that during treatment of a lesion in the left external iliac artery the advance 35 lp low profile balloon burst.The approach was ipsilateral from the left common femoral artery, described as having severe calcification extending from the common femoral artery to the external iliac artery.The balloon was inflated to 10 atmospheres when the burst occurred.The direction of burst is unknown.Another manufacturer's balloon, the "mustang/bsj," was used to successfully complete the procedure.No adverse events have been reported regarding this occurrence.
Additional Manufacturer Narrative
Corrected information: report source: foreign, user facility, company representative.Investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), 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.Catheter was smooth, clean and not damaged.4 pinhole leaks noted at approximately 4.5cm from the distal end (middle of balloon).The balloon length measured within specifications at 7mm.The balloon did not burst.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.There was a severe calcification per the physician.Although the balloon did not rupture on the calcification, it is feasible to suggest the calcification may have contributed to the pinholes.Per the ifu, "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." based upon the information provided, the characteristics displayed, and examination of the returned device, it is plausible to suggest that this incident was human anatomy related.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: 6751976
• Report Number: 1820334-2017-02104
• Device Sequence Number: 725216
• Product Code: DQY
• UDI-Device Identifier: 10827002523477
• UDI-Public: (01)10827002523477(17)180218(10)5661001
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• 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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: PTA5-35-80-6-8.0
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/20/2017
• Supplement Date Received by Manufacturer: 10/13/2017
• Initial Report FDA Received Date: 07/28/2017
• 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