MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINN FG GATEWAY OTW US 1.50MM X 9MM; CATHETER, BALLOON TYPE

Model Number	M0032072209150
Medical Device Problem Code	Hole In Material (1293)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/04/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon was found not to be sealed during the procedure.There were no reported clinical consequences to the patient.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The subject device was returned wrapped around itself and the guidewire used with the balloon catheter was not returned.Visual inspection revealed that the balloon catheter of the inflation port appeared to have a hole.During functional testing, 0.014" demonstration guidewire was introduced and advanced through the catheter proximal end exited through the distal end without any friction.During inflation testing, the balloon would not inflate normally, water was leaking through the guidewire port from the opening in the inflation port.The inner shaft under the hub appeared to be perforated causing the leak and the balloon could not stay inflated due to the inner leak under the hub's inflation port.No other anomalies were observed.It is possible that the guidewire was inserted into the inflation port instead of the guidewire back port causing the analyzed puncture/leakage directly within the hub inflation port which caused the leak and resulted in the balloon failing to inflate.The physician may have perceived the observed inflation port hole as the hole in the balloon, but no anomalies were noted on the balloon section of the catheter.However, based on the limited information currently available, a definitive cause of the reported and analyzed issues could not be determined.Therefore a cause of undeterminable will be assigned to this investigation.
Event or Problem Description
It was reported that the balloon was found not to be sealed during the procedure.There were no reported clinical consequences to the patient.

• Brand Name: FG GATEWAY OTW US 1.50MM X 9MM
• Common Device Name: CATHETER, BALLOON TYPE
• Manufacturer (Section D): BOSTON SCIENTIFIC - MINN; one scimed place; maple grove MN 55311
• MDR Report Key: 7149795
• Report Number: 3008853977-2017-00060
• Device Sequence Number: 1890251
• Product Code: GBA
• UDI-Device Identifier: 08714729791201
• UDI-Public: (01)08714729791201(17)180930(10)18397727
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: H050001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2018

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: 09/30/2018
• Device Model Number: M0032072209150
• Device Catalogue Number: M0032072209150
• Device Lot Number: 18397727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2017
• Initial Date Received by Manufacturer: 12/04/2017
• Supplement Date Received by Manufacturer: 02/09/2018
• Initial Report FDA Received Date: 12/27/2017
• Supplement Report FDA Received Date: 03/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1