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	03/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been requested and not yet received.The event is currently under investigation.
Event or Problem Description
It was reported that during an antegrade approach with right femoral puncture - angioplasty to right sfa, using an advance 35 low profile balloon catheter, the balloon ruptured during the 3rd inflation.The targeted lesion was located in the mid to upper third of the sfa.There was vessel calcification noted but no angulation.Inflation pressure used was reported to be 10atm.Type of contrast used was a mix of 50/50 contrast to saline.Additionally, it was reported that the balloon ruptured circumferentially.The ruptured balloon could not be withdrawn however from the introducer therefore the introducer and damaged balloon had to be removed over the guidewire.Another introducer was placed and the procedure was completed.It was also reported the operator said the case was "technically difficult".No section of the device remained inside of the patient's body.The patient did not require any additional procedures due to this occurrence.The patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
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.The visual inspection of the returned device revealed that the balloon was separated in two pieces, but still attached.The balloon ruptured radially (2cm from the distal end) and longitudinally (2cm long 2cm from the distal end).A document based investigation evaluation was also performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were 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 include: device description: "the balloon is manufactured from an extra-thin wall, high-strength, minimally-compliant material.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.Refer to label for further information.Use of a pressure gauge is recommended to monitor inflation pressures." 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.Do not use power injector for balloon inflation of contrast medium through catheter lumen marked "distal." rupture may occur." instructions for use: "upon removal from package, inspect the catheter to ensure no damage has occurred during shipping." balloon introduction and inflation: "inflate balloon to desired pressure adhere to recommended balloon inflation pressures.If balloon pressure is lost and/or balloon rupture occurs, deflate balloon and remove balloon and sheath as a unit." based on all the available information and the results of the investigation there is not enough information to confirm if the balloon actually ruptured radially or was torn radially upon removal over the guide wire.According to the ifu, "if balloon pressure is lost and/or balloon rupture occurs, deflate balloon and remove balloon and sheath as a unit." the device was not removed in the manner directed by the ifu.In addition, the physician reported that the case was "technically difficult" and that the device burst at 10 atm.Nominal pressure for the device per the ifu is 10 atm.Use of a pressure gauge is recommended to monitor inflation pressures.The most likely root cause of the reported event may be attributed to user/ operational technique and/or the patient's anatomy.We will continue to monitor for similar complaints.Per the quality engineering risk assessment, no further action is required.

• 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: 6507107
• Report Number: 1820334-2017-00639
• Device Sequence Number: 13609975
• Product Code: DQY
• UDI-Device Identifier: 10827002523521
• UDI-Public: (01)10827002523521(17)191018(10)7366846
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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): 07/18/2017

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: PTA5-35-80-7-4.0
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/22/2017
• Supplement Date Received by Manufacturer: 04/21/2017
• Initial Report FDA Received Date: 04/20/2017
• Supplement Report FDA Received Date: 07/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1