MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET SOLENT PROXI; CATHETER, CONTINUOUS FLUSH

Model Number	45032
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event was approximated, as no event date was reported.
Event or Problem Description
It was reported that there was a hole in the catheter.An angiojet solent proxi catheter was selected for use.During procedure while inside the patient, a hole in the catheter was observed.The procedure was completed successfully and there were no patient complications reported.
Event or Problem Description
It was reported that there was a hole in the catheter.An angiojet solent proxi catheter was selected for use.During procedure while inside the patient, a hole in the catheter was observed.The procedure was completed successfully and there were no patient complications reported.It was further reported that the hole was leaking blood and fluid.Device evaluated by mfr: the pump, spike line, effluent/supply line, shaft and tip were microscopically and visually inspected.There were numerous kinks throughout the device.Functional testing revealed the device ran within normal range without any errors or alarms; however, fluid did leak from the shaft.The shaft was microscopically inspected and a hole in the shaft was revealed 3.8cm distal of the strain relief.Inspection of the remainder of the device presented no other damage or irregularities.
Additional Manufacturer Narrative
Date of event was approximated as no event date was reported.

• Brand Name: ANGIOJET SOLENT PROXI
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7911064
• Report Number: 2134265-2018-61293
• Device Sequence Number: 11278614
• Product Code: DXE
• UDI-Device Identifier: 08714729889595
• UDI-Public: 08714729889595
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K101406
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2018

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: 05/13/2020
• Device Model Number: 45032
• Device Catalogue Number: 45032
• Device Lot Number: 0022420495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2018
• Initial Date Received by Manufacturer: 09/11/2018
• Supplement Date Received by Manufacturer: 09/27/2018
• Initial Report FDA Received Date: 09/26/2018
• Supplement Report FDA Received Date: 10/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1