MAUDE Adverse Event Report: COOK INC ADVANCE 14 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	07/06/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: terumo destination 5fr, asahi intecc treasure xs, kaneka's balloon bandicoot.(b)(6).The event is currently under investigation.
Event or Problem Description
It was reported that during a pta procedure of a patient with a lesion that was mildly calcified, the balloon ruptured.The device was advanced from the right groin to the left superficial femoral artery (sfa) through a 5fr guiding sheath and a wire guide, both from other manufacturer's.During balloon inflation up to 16 atmospheric pressure (atm) in the lesion, the balloon ruptured prior to reaching to 16 atm.Balloons from two different manufacturer's were used as replacements to successfully complete the procedure.The patient did not require any medical or surgical intervention due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Concomitant medical products: terumo destination 5fr.Asahi intecc treasure xs.Kaneka's balloon bandicoot.(b)(6).(b)(4).Investigation - evaluation: a review of the complaint history, device history record, documentation, instructions for use ( ifu), specifications, trends, quality control and visual inspection of the returned device was conducted during the investigation.There is no evidence to suggest the product was not made to specifications.There are no other reported complaints for this lot number.The device is shipped with an instruction for use (ifu) that describes the intended use, specific items are addressed such as: warnings ¿do not exceed rated burst pressure.Rupture of balloon may occur.Adhere to balloon inflation pressure parameters in the compliance card insert.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.¿ one partial, used advance 14 lp low profile balloon catheter was returned for evaluation.Functional testing reveals a pin hole in the catheter shaft approximately 2 cm proximal of the balloon.No additional evaluation of the device could performed since the device was only partially returned based on the information provided, examination of the returned device and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
Event or Problem Description
It was reported that the balloon ruptured during a pta procedure of a patient with a mildly calcified lesion.The device was advanced from the right groin to the left superficial femoral artery (sfa) through a 5fr guiding sheath and a wire guide, both from other manufacturer's.The balloon ruptured during inflation prior to reaching 16 atm.Balloons from two different manufacturer's were used as replacements to successfully complete the procedure.The patient did not require any medical or surgical intervention due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• 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: 5844104
• Report Number: 1820334-2016-00762
• Device Sequence Number: 16247351
• Product Code: DQY
• UDI-Device Identifier: 10827002503387
• UDI-Public: (01)10827002503387(17)181112(10)6374648
• 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,user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2016

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: PTAX4-14-170-4-12
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/06/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/03/2016
• Supplement Report FDA Received Date: 12/23/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1