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

Model Number	80618
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/07/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that microcatheter was fractured.The target lesion was in the gastroduodenal artery.A 155 direxion was selected for use.During the procedure, it was noted that the microcatheter was fractured and was simply removed from the patient's body without any intervention.The procedure was completed with another of the same device.No complications reported and patient was stable.
Event or Problem Description
It was reported that microcatheter was fractured.The target lesion was in the gastroduodenal artery.A 155 direxion was selected for use.During the procedure, it was noted that the microcatheter was fractured and was simply removed from the patient's body without any intervention.The procedure was completed with another of the same device.No complications reported and patient was stable.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Returned product consisted of a direxion microcatheter with a guide wire in the shaft of the device.The device was bloody.Analysis of the tip, inner/outer shaft, and hub/strain relief included microscopic and visual inspection.Inspection revealed a complete separation of the shaft 18cm from the strain relief, and the inner shaft was stretched for 22.6cm between the separated ends.Inspection of the rest of the device found no other damage or defect.

• 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: 9933553
• Report Number: 2134265-2020-04448
• Device Sequence Number: 10954113
• Product Code: KRA
• UDI-Device Identifier: 08714729839361
• UDI-Public: 08714729839361
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K142259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2020

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 Expiration Date: 05/13/2021
• Device Model Number: 80618
• Device Catalogue Number: 80618
• Device Lot Number: 0023787605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Initial Date Received by Manufacturer: 03/23/2020
• Supplement Date Received by Manufacturer: 10/02/2020
• Initial Report FDA Received Date: 04/07/2020
• Supplement Report FDA Received Date: 10/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Weight: 66