MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINN GUIDER/ST XF/6FR/100 CM; CATHETER, PERCUTANEOUS

Catalog Number	M003101500
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/07/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is not available.
Event or Problem Description
It was reported that during the procedure, the guide catheter leaked.No consequences to the patient were reported.

• Brand Name: GUIDER/ST XF/6FR/100 CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MINN; one scimed place; maple grove MN 55311
• MDR Report Key: 6136808
• Report Number: 0002134265-2016-00034
• Device Sequence Number: 358124
• Product Code: DQY
• UDI-Device Identifier: 08714729244370
• UDI-Public: (01)08714729244370(17)190531(10)19343300
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K980453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/07/2016

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 Catalogue Number: M003101500
• Device Lot Number: 19343300
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2016
• Initial Report FDA Received Date: 11/30/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1