MAUDE Adverse Event Report: COOK INC ATB ADVANCE BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/15/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported that during a left upper extremity fistulgram procedure on the (b)(6) female patient, the balloon catheter broke completely apart during removal from another manufacturer's sheath.The broken portion was removed by removing the sheath and wire together.The procedure was completed with a second complaint device.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Additional information was provided by the clinical specialist indicating "the balloon was deflated before removing from sheath." 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 instruction for use (ifu) that describes the intended use, specific items are addressed such as: warnings- do not exceed rated burst pressure.Rupture of balloon may occur.Adhere to balloon inflation pressure parameters in fig.1.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.The visual inspection of the returned device reported the product was returned in 2 segments to assist in the investigation.The separation occurred in the catheter shaft; the balloon was fully intact.The proximal segment was 47.7cm long.Starting at 27 cm distal the hub and through the remainder of this segment elongation was noted.Additionally, a kink was noted at 42.7 cm from the proximal end.The distal segment is 9.9 cm in length with elongation along the proximal 3 cm.Based on the damage displayed, it is likely that this catheter was exposed to excess forces.The device history record was reviewed and no non-conformances were noted.There is no evidence to suggest the product was not made to specifications.We will continue to monitor for similar complaints.Per the risk assessment no further action is required.Blank fields on this form indicate the information is unknown or unavailable.
Event or Problem Description
It was reported that during a left upper extremity fistulgram procedure on the (b)(6) female patient, the balloon catheter broke completely apart during removal from another manufacturer's sheath.The broken portion was removed by removing the sheath and wire together.The procedure was completed with a second complaint device.Additional information was provided stating that the balloon was deflated before removing from sheath.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

• Brand Name: ATB ADVANCE BALLOON CATHETER
• Common Device Name: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5789698
• Report Number: 1820334-2016-00591
• Device Sequence Number: 11104341
• Product Code: DQY
• UDI-Device Identifier: 00827002268890
• UDI-Public: (01)00827002268890(17)171202(10)6420794
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K033875
• 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): 06/15/2016
• Report Date (Section F): 06/15/2016

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: ATB5-35-40-8-4.0
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 06/15/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/13/2016
• Supplement Report FDA Received Date: 01/12/2017
• 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
• Patient Age: 74 YR