MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINN FG GATEWAY OTW US 3.00MM X 15MM; CATHETER, BALLOON TYPE

Catalog Number	M0032072215300
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/10/2017
Type of Reportable Event	Malfunction
Event or Problem Description
During the inspection, it was reported that the subject balloon found leaked.The procedure was completed with another balloon.There was no clinical consequences to the patient.
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.During the analysis of the returned device, no anomalies were observed.During the functional testing, no anomalies were observed and no leaks were observed.The device met all manufacturing specifications.Therefore the reported issue could not be confirmed.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
Event or Problem Description
During the inspection, it was reported that the subject balloon found leaked.The procedure was completed with another balloon.There was no clinical consequences to the patient.

• Brand Name: FG GATEWAY OTW US 3.00MM X 15MM
• Common Device Name: CATHETER, BALLOON TYPE
• Manufacturer (Section D): BOSTON SCIENTIFIC - MINN; one scimed place; maple grove MN 55311
• MDR Report Key: 6390347
• Report Number: 0002134265-2017-30005
• Device Sequence Number: 19015952
• Product Code: NJE
• UDI-Device Identifier: 08714729791393
• UDI-Public: (01)08714729791393(17)190131(10)18806489
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/27/2017

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: 01/31/2019
• Device Catalogue Number: M0032072215300
• Device Lot Number: 18806489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/10/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/08/2017
• Supplement Report FDA Received Date: 06/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1