MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINN GUIDER/ST XF/8FR/90CM; CATHETER, PERCUTANEOUS

Catalog Number	H965100520
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/18/2016
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 proximal part of the guide catheter (subject device) leaked.No consequences to the patient were reported.
Additional Manufacturer Narrative
The subject device has returned to stryker's international office and is in route to stryker's us office.
Event or Problem Description
It was reported that during the procedure, the proximal part of the guide catheter (subject device) leaked.No consequences to the patient were reported.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.Visual and microscopic investigation of the returned device found that the guide catheter was kinked on its proximal shaft at approximately 25.0cm proximal to its distal end and compressed on its distal shaft at 2.0cm and 5.0cm from its distal end.No other anomalies were observed with the guider catheter.The catheter distal end was plugged with a.085" mandrel and the device was flushed with water and the fluid was leaking from the catheter hub.It could not be definitively determined what caused the analyzed anomalies of the guide catheter to become kinked/bent and compressed because they were not reported or previously mentioned.The investigation found that there was no leak from the guide catheter shaft but the hub which remains outside the patient during use.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
It was reported that during the procedure, the proximal part of the guide catheter (subject device) leaked.No consequences to the patient were reported.

• Brand Name: GUIDER/ST XF/8FR/90CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MINN; one scimed place; maple grove MN 55311
• MDR Report Key: 5660666
• Report Number: 0002134265-2016-00001
• Device Sequence Number: 13537341
• Product Code: DQY
• UDI-Device Identifier: 08714729202561
• UDI-Public: (01)08714729202561(17)181231(10)18725364
• Combination Product (Y/N): N
• Initial Reporter Country: SE
• PMA/510(K) Number: K980453
• 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,Followup
• Report Date (Section B): 04/20/2016

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: 12/31/2018
• Device Catalogue Number: H965100520
• Device Lot Number: 18725364
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/20/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/17/2016
• Supplement Report FDA Received Date: 07/13/2016; 09/20/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1