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
This current report represents the initial and supplemental 01 report for this event.The original initial report number ¿0002134265-2016-00034¿ for this event should be deleted from the emdr system.The information contained within this report represents information contained in the original report number listed above and any supplemental information gathered that was not previously provided to fda.A final report (emdr supplemental 02) will be sent once the product investigation is completed.The information in this current report was not provided as a supplemental report to the original report number listed above because the original initial mdr report number may now considered a duplicate report number by fda¿s emdr system.¿.
Event or Problem Description
It was reported that during the procedure the guide catheter leaked.No consequences to the patient were reported.
Additional Manufacturer Narrative
Analysis of the returned device revealed that the guide catheter was found to be leaking between the hub and proximal shaft, indicating that the leak originated from the hub.The guider was kinked on its shaft at approximately 32.0cm and 88.5cm from its proximal end.The found catheter damage (guide catheter shaft kinked) does not relate to the reported guide catheter leak because the locations of the damages are not in the same location as the leak.However, it is unknown what caused the found guide catheter shaft kinked.Based on the information available and device analysis it is confirmed that the leak originated from the hub and not the catheter shaft.Therefore the reported issue of the guide catheter shaft leak 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.
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: 6559292
• Report Number: 0002134265-2017-30030
• Device Sequence Number: 74702
• 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,Followup
• Report Date (Section B): 06/28/2017

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: 05/31/2019
• Device Catalogue Number: M003101500
• Device Lot Number: 19343300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/10/2017
• Supplement Report FDA Received Date: 06/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1