MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK OCCLUSION BALLOON CATHETER; CATHETER, PERCUTANEOUS

Model Number	M001171020
Medical Device Problem Codes	Leak/Splash (1354); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr: unit returned with its original pouch.The returned device matches with upn and lot provided by the customer.The body of the balloon was found crazing producing several holes.The balloon was inflated and a leak was found due to the holes located in the body of the balloon.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).
Event or Problem Description
Reportable based on analysis completed on 24nov2016.It was reported that balloon leak occurred.A 7/2/65 occlusion balloon catheter was selected for use.During preparation, when the physician flushed the wire port and pre-tested the balloon with saline syringe, a leak was noted from the balloon.The device did not enter the patient's body.No patient complications were reported.  however, returned device analysis revealed balloon pinhole.

• Brand Name: OCCLUSION BALLOON CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• MDR Report Key: 6162617
• Report Number: 2134265-2016-11375
• Device Sequence Number: 19017164
• Product Code: DQY
• UDI-Device Identifier: 08714729112389
• UDI-Public: (01)08714729112389(17)20161231(10)18186511
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K062202
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/24/2016

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 Expiration Date: 12/31/2016
• Device Model Number: M001171020
• Device Catalogue Number: 17-102
• Device Lot Number: 18186511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2016
• Initial Report FDA Received Date: 12/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1