MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINN GUIDER/40 DEG XF/6FR/100 CM; CATHETER, PERCUTANEOUS

Model Number	M003101420
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is not available.
Event or Problem Description
It was reported that the guide catheter (subject device) was cracked /broken.There were no patient clinical consequences reported.
Additional Manufacturer Narrative
Analysis of the device revealed that the guider was kinked at 13.0cm, 46.0cm and 86.5cm from its proximal.The guide catheter tip was not found to be broken.The guider distal tip lumen was examined and it was also found to be conforming to its visual specifications.No anomalies were observed with the guider proximal and distal lumens and hence the reported guide catheter break was not confirmed.During functional evaluation, the guide catheter was found to be leaking between the hub and proximal shaft, indicating that the leak originated from the hub.The hub leak is an issue in which product fails to meet specification.While review of the manufacturing records did not reveal that the device failed to meet specifications upon release, the observed hub leak appeared to be potentially manufacturing related and the manufacturer continues to investigate the matter.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 the guide catheter (subject device) was cracked /broken.There were no patient clinical consequences reported.

• Brand Name: GUIDER/40 DEG 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: 6704409
• Report Number: 3008853977-2017-00007
• Device Sequence Number: 881896
• Product Code: DQY
• UDI-Device Identifier: 08714729244295
• UDI-Public: (01)08714729244295(17)190430(10)19173033
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Report Date (Section B): 09/22/2017

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: 04/30/2019
• Device Model Number: M003101420
• Device Catalogue Number: M003101420
• Device Lot Number: 19173033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2017
• Initial Date Received by Manufacturer: 06/14/2017
• Supplement Date Received by Manufacturer: 08/25/2017
• Initial Report FDA Received Date: 07/11/2017
• Supplement Report FDA Received Date: 09/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1