MAUDE Adverse Event Report: COOK INC ADVANCE 35 LP LOW PROFILE BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Model Number	N/A
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/04/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pt identifier) information not provided by reporter.Age at time of event, date of birth) information not provided by reporter.Sex) information not provided by reporter.Weight) information not provided by reporter.(b)(4).The event is currently under investigation.
Event or Problem Description
During a fistulogram procedure, the advance 35 lp low profile balloon catheter burst circumferentially.It appears part of the balloon may have sheared off inside the patient.
Additional Manufacturer Narrative
(b)(4).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.The device is shipped with an instruction for use (ifu) that describes the intended use, specific items are addressed such as: do not exceed rated burst pressure and do not use a power injector for balloon inflation or injection of contrast medium as rupture may occur.The ifu also states, if balloon pressure is lost and/or balloon rupture occurs, deflate balloon and remove balloon and sheath as a unit.The nominal inflation for this device is 8 atm and the rated burst pressure is 11 atm.End user reported that the pressure used exceeded the labeled burst pressure.The returned balloon was inverted suggesting that the physician attempted to withdraw the balloon through the competitor sheath.After rupture, attempts to remove through an introducer/sheath (against the ifu) would be difficult as the balloon cannot be fully deflated, making rewrap more difficult on a balloon.A balloon that burst circumferentially has an even more difficult time with rewrap, which increases the potential for separation.The device is designed to burst linearly.However, a balloon may burst or tear circumferentially due to angulation or calcification.Calcifications can have unexpected sharp protrusions which can damage the balloon and contribute to burst or tear.It is unknown whether there was any vessel calcification.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.Based on the investigation evaluation, the failure mode was likely caused by off label use of the device.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
Event or Problem Description
During a fistulagram procedure, the advance 35 lp low profile balloon catheter burst circumferentially.It appears part of the balloon may have sheared off inside the patient.

• 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: 5663268
• Report Number: 1820334-2016-00373
• Device Sequence Number: 10775973
• Product Code: DQY
• UDI-Device Identifier: 10827002523750
• UDI-Public: (01)10827002523750(17)180710(10)6022652
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K091527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: PTA5-35-80-10-8.0
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/04/2016
• Device Age: 10 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/11/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/18/2016
• Supplement Report FDA Received Date: 11/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other