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	07/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The reported device is not available for evaluation.The event is currently under investigation.
Event or Problem Description
It is alleged that an advance 35 lp low profile balloon catheter was being used to treat an occluded superficial femoral artery when the balloon ruptured.It was reported that the device was being inflated within an extensive amount of calcification.The pressure at which the device was inflated at the time of rupture is unknown, as well as the direction of the rupture.Allegedly, another device of the same kind was then used to successfully complete the procedure.No adverse events have been reported regarding this occurrence.
Additional Manufacturer Narrative
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.The device had kinks at 14.5cm and 34.0cm from the proximal end.A longitudinal burst was noted 1.5cm in length.The balloon length measured within specifications.Catheter length measured within specifications.A document-based investigation was performed.Review of the device history record shows two nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.The patient had vessel tortuosities and the balloon was inflated in a calcified site.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." also, the contrast medium to saline mixture is unknown.Based upon the information provided, the characteristics displayed, and examination of the returned product, it is plausible to suggest that this incident was technique related or 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: 6752050
• Report Number: 1820334-2017-02200
• Device Sequence Number: 13499633
• Product Code: DQY
• UDI-Device Identifier: 10827002523378
• UDI-Public: (01)10827002523378(17)180218(10)5660995
• 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: foreign,health professional,u
• 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: PTA5-35-80-5-2.0
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/25/2017
• 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