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	10/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No known impact or consequence to patient.Material rupture is labeled in the ifu.The event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
Two advance 35 lp low profile balloon catheters were used in a percutaneous transluminal angioplasty of the superficial femoral artery.It was reported that the first balloon (1820334-2017-03626) burst at the intersection, but was still able to be pulled through the introducer, and removed without difficulty.A second balloon (1820334-2017-03627) ripped apart into two pieces and was retrieved with a snare.According to the initial reporter, 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, and the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, dimensional verification, device history record, instructions for use (ifu), manufacturing instructions, specifications, quality control, visual inspection and functional testing of the returned device was conducted during the investigation.One used advance 35 lp low profile balloon catheter was returned for examination.Balloon was separated at the proximal balloon bond into two sections.Both marker bands were present.The catheter shaft was accordion at the distal tip portion under balloon.Proximal and distal measurements of the balloon were out of specification.The balloon burst both radially and longitudinally.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.A review of the device history record of the finished product shows no nonconforming events.There were no other reported complaints for this lot number.The customer stated the balloon was inflated according to packaging.The customer also stated that vessel calcification was present.Based on the information provided, examination of the returned product, and the results of our investigation; a definitive root cause could not be determined.However, it is likely that patient anatomy contributed to the device failure.Appropriate measures have been initiated to address this failure mode.The 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: 6966784
• Report Number: 1820334-2017-03626
• Device Sequence Number: 1297482
• Product Code: DQY
• UDI-Device Identifier: 10827002523453
• UDI-Public: (01)10827002523453(17)200615(10)7993402
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2018

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: PTA5-35-80-6-4.0
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/12/2017
• Supplement Date Received by Manufacturer: 01/18/2018
• Initial Report FDA Received Date: 10/20/2017
• Supplement Report FDA Received Date: 01/18/2018
• Patient Sequence Number: 1