MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINN FG GATEWAY OTW US 2.50MM X 15MM; CATHETER, BALLOON TYPE

Catalog Number	M0032072215250
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is unavailable to manufacturer.
Event or Problem Description
It was reported that the balloon catheter (subject device) was fractured at the hub.There were no reported clinical consequences to the patient due to this event.
Event or Problem Description
It was reported that the balloon catheter(subject device) was fractured at the hub.There were no reported clinical consequences to the patient due to this event.
Additional Manufacturer Narrative
Expiration date - added.Product available to stryker ¿ updated.Returned to manufacturer on ¿updated.Device evaluated by mfg ¿updated.Summary attached - updated.Manufacturing date ¿ added.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.During analysis, the returned device was visually inspected and no defects were noted to the hub or catheter shaft.Following the functional test, the device was flushed with no difficulty and the balloon was inflated and deflated without any issues.No leaks were noted around the hub of the device.Based on analysis, the as reported "balloon catheter broken inside patient" was not 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.

• Brand Name: FG GATEWAY OTW US 2.50MM X 15MM
• Common Device Name: CATHETER, BALLOON TYPE
• Manufacturer (Section D): BOSTON SCIENTIFIC - MINN; one scimed place; maple grove MN 55311
• MDR Report Key: 8918910
• Report Number: 3008853977-2019-00059
• Device Sequence Number: 1828858
• Product Code: GBA
• UDI-Device Identifier: 08714729791409
• UDI-Public: 08714729791409
• 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): 11/04/2019

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: 09/04/2021
• Device Catalogue Number: M0032072215250
• Device Lot Number: 22608649
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2019
• Initial Date Received by Manufacturer: 08/06/2019
• Supplement Date Received by Manufacturer: 10/21/2019
• Initial Report FDA Received Date: 08/21/2019
• Supplement Report FDA Received Date: 11/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1