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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Device evaluated by manufacturer: the device was returned for analysis.The device shaft was analyzed for any damage.The devices shaft showed 1 fracture located 3.5cm from the hub.The shaft showed a separation located 30.5cm from the hub.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.A fracture and separation were confirmed.
Event or Problem Description
Reportable based on device analysis completed on 04oct2021.It was reported that device fractured at the hub.A direxion catheter-infusion was selected for use.The catheter surface was hydrated prior to removal from carrier hoop.However, upon removing the catheter from the hoop, the nitinol tubing was disconnected from the hub due to excessive force by the physician.The procedure was completed with another of same device.No patient complications were reported.However, device analysis revealed that the shaft was separated 30.5cm from the hub.

• 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: 12689607
• Report Number: 2134265-2021-12852
• Device Sequence Number: 11803621
• Product Code: KRA
• UDI-Device Identifier: 08714729839392
• UDI-Public: 08714729839392
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K142259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/25/2021

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: 06/02/2023
• Device Model Number: 80618
• Device Catalogue Number: 80618
• Device Lot Number: 0027426343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 10/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1