MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DIREXION; CATHETER, CONTINUOUS FLUSH

Model Number	80618
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/16/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter broke.A direxion microcatheter was selected for use in an embolization procedure.Midway through the procedure, the catheter broke into two pieces.Both pieces were removed from the body and no additional intervention was required for removal.A second catheter was used to complete the procedure.No patient complications were reported and the patient was in stable condition post procedure.
Additional Manufacturer Narrative
Device evaluated by manufacturer: returned product consisted of a direxion infusion catheter in two pieces.The device guidewire was loaded in the distal portion of the separated pieces.Analysis of the tip, inner / outer shaft and hub / strain relief included microscopic and visual inspection.Inspection revealed a complete inner/outer shaft break located 19.3cm from the strain relief with an additional outer shaft fracture 118cm form the strain relief.The inner shaft was stretched 136cm from the tip.Inspection of the rest of the device found no other damage or defects.
Event or Problem Description
It was reported that the catheter broke.A direxion microcatheter was selected for use in an embolization procedure.Midway through the procedure, the catheter broke into two pieces.Both pieces were removed from the body and no additional intervention was required for removal.A second catheter was used to complete the procedure.No patient complications were reported and the patient was in stable condition post procedure.

• Brand Name: DIREXION
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10333422
• Report Number: 2134265-2020-10022
• Device Sequence Number: 10965628
• Product Code: KRA
• UDI-Device Identifier: 08714729839323
• UDI-Public: 08714729839323
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K142259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2020

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 Model Number: 80618
• Device Catalogue Number: 80618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Initial Date Received by Manufacturer: 07/16/2020
• Supplement Date Received by Manufacturer: 08/24/2020
• Initial Report FDA Received Date: 07/28/2020
• Supplement Report FDA Received Date: 09/14/2020
• Patient Sequence Number: 1