MAUDE Adverse Event Report: COOK INC ADVANCE 18 LP LOW PROFILE BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Model Number	N/A
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	07/15/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant products: terumo 5fr sheath, 035 terumo wire and terumo 018 muso peripheral guide wire.(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported during a fistulaplasty, using another manufacturer's sheath, the balloon catheter burst circumferentially below the inflation pressure limits.The tip of the balloon polymer tip detached from the balloon a vascular snare was used to remove the fragment.The reporter stated she was "unsure, perhaps some off the balloon material" remained in the patient and that additional procedure was required due to the event.The patient reportedly experienced extra bruising, pain and was exposed to additional radiation due to the adverse event.
Additional Manufacturer Narrative
Concomitant medical products: terumo 5fr sheath, 035 terumo wire and terumo 018 muso peripheral guide wire (b)(4).Investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, quality control and visual inspection of the returned device was conducted during the investigation.The device is shipped with an 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 visual inspection of the returned device confirms rupture and circumferential separation.The proximal segment of the balloon measures approximately 0.5cm.The distal segment of the balloon was not returned to assist in the investigation.Per the description of the event, "balloon burst during inflation circumferential burst.Distal end of balloon detached when trying to remove through sheath." withdrawal of a ruptured balloon through the sheath is known to contribute to circumferential separations and is against the ifu recommendations.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.We will continue to monitor for similar complaints.Per the risk assessment no further action is required.
Event or Problem Description
It was reported during a fistulaplasty, using another manufacturer's sheath, the balloon catheter burst circumferentially below the inflation pressure limits.The tip of the balloon polymer tip detached from the balloon a vascular snare was used to remove the fragment.The reporter stated she was "unsure, perhaps some off the balloon material" remained in the patient and that additional procedure was required due to the event.The patient reportedly experienced extra bruising, pain and was exposed to additional radiation due to the adverse event.

• Brand Name: ADVANCE 18 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: 5871529
• Report Number: 1820334-2016-00792
• Device Sequence Number: 556587
• Product Code: DQY
• UDI-Device Identifier: 10827002502564
• UDI-Public: (01)10827002502564(17)171222(10)5534250
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K073378
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2016

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: PTA4-18-80-7-4
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/12/2016
• Supplement Report FDA Received Date: 11/04/2016
• 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: Required Intervention