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

Model Number	M003101620
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/07/2017
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, a leak was found between the hub and the catheter.No clinical 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.The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed.Although there are many potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause and because the product was not returned for analysis, a cause of undeterminable was assigned.
Event or Problem Description
It was reported that during the procedure, a leak was found between the hub and the catheter.No clinical consequences to the patient were reported.

• 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: 6919461
• Report Number: 3008853977-2017-00036
• Device Sequence Number: 19039467
• Product Code: DQY
• UDI-Device Identifier: 08714729283539
• UDI-Public: (01)08714729283539(17)181031(10)18571307
• Combination Product (Y/N): N
• 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): 12/11/2017

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: 10/31/2018
• Device Model Number: M003101620
• Device Catalogue Number: M003101620
• Device Lot Number: 18571307
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2017
• Supplement Date Received by Manufacturer: 11/17/2017
• Initial Report FDA Received Date: 10/06/2017
• Supplement Report FDA Received Date: 12/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1