MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINN GUIDER 40XF 5F 100CM; CATHETER, PERCUTANEOUS

Catalog Number	M003101620
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that a crack was found in the guide catheter.There were no reported clinical consequences to the patient.
Event or Problem Description
It was reported that a crack was found in the guide catheter.There were no reported clinical consequences to the patient.
Additional Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.Visual inspection revealed that the guide catheter hub was cracked from the proximal end.No other anomalies were noted.During functional testing, the catheter was plugged with a mandrel and was flushed with water.The fluid was found to be leaking through the crack at hub.It is possible that the hub may have been damaged as a result of rough handling when opening the package.However the reported event of catheter shaft break was not confirmed during analysis.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: GUIDER 40XF 5F 100CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MINN; one scimed place; maple grove MN 55311
• MDR Report Key: 8493944
• Report Number: 3008853977-2019-00031
• Device Sequence Number: 1955646
• Product Code: DQY
• UDI-Device Identifier: 08714729283539
• UDI-Public: 08714729283539
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K010853
• 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): 06/13/2019

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: 01/22/2021
• Device Catalogue Number: M003101620
• Device Lot Number: 21646776
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2019
• Initial Date Received by Manufacturer: 03/21/2019
• Supplement Date Received by Manufacturer: 05/28/2019
• Initial Report FDA Received Date: 04/08/2019
• Supplement Report FDA Received Date: 06/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1