MAUDE Adverse Event Report: COOK INC ADVANCE 35 LP LOW PROFILE BALLOON CATHETER; LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	N/A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not yet returned for evaluation.
Event or Problem Description
It was reported an inflation device, low profile balloon catheter, popped during inflation.Additional information has been requested but not provided at the time of this report.
Additional Manufacturer Narrative
Investigation- a review of the device history record did not reveal conditions that could have contributed to the reported event.No similar complaints have been reported for this lot number.Due to the device not returning, a definitive root cause is undetermined.Per information provided by the area representative that was present during the procedure, the pta5-35-135-3-6.0 advance 35 lp low profile balloon catheter, lot 5566649 ruptured as the atmospheric pressure increased.Actual inflation rate is unknown, but it is stated that the surgeon normally inflates to the rated burst pressure or higher (14-20atm).It is reported that the pta5-35-135-3-6.0 advance 35 lp low profile balloon catheter, lot 5566649 burst during the second or third inflation.It is unknown as to whether the balloon burst longitudinally or circumferentially.It is reported that the sheath and balloon were not removed as a unit.No section of the device remained in the patient.The patient did not require any additional procedures nor did the alleged failure contribute to any adverse effects or injuries to the patient.Labeling for the device provides documentation that the rated burst pressure for the pta5-35-135-3-6.0 advance 35 lp low profile balloon catheter is less than or equal to 15 atm/bar, with nominal pressure of 10 atm/bar.Per the instructions for use, ¿particular care should be taken in handling the balloon to prevent damage.It will inflate to the indicated size parameters when utilizing proper pressure recommendations.Adhere to balloon inflation pressure parameters indicated in the compliance card insert.Use only the recommended balloon inflation medium.Never use air or any gaseous medium to inflate the balloon.If balloon pressure is lost and/or balloon rupture occurs, deflate balloon and remove balloon and sheath as a unit¿.A quality engineer risk assessment was conducted to assess the risk of this failure mode and concluded a changed is not required, thus no risk reduction activities are required at this time.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.

• Brand Name: ADVANCE 35 LP LOW PROFILE BALLOON CATHETER
• Common Device Name: LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6245767
• Report Number: 1820334-2017-00057
• Device Sequence Number: 13653923
• Product Code: LIT
• UDI-Device Identifier: 10827002343754
• UDI-Public: (01)10827002343754(17)180109(10)5566649
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K132020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2016

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: PTA5-35-135-3-6.0
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/12/2017
• Supplement Report FDA Received Date: 03/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1