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

Model Number	80618
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The device shaft was analyzed for any damage.The device shaft showed one fracture located 25.5cm from the hub.The shaft was not completely separated the inner liner was still connected.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.
Event or Problem Description
Reportable based on device analysis completed on 03sep2021.It was reported that the device was bent.The target lesion was located in the iliac area.A direxion catheter-infusion was selected for use.During the preparation, the catheter surface was hydrated prior to removal from carrier hoop.However, it was noted that the device got bent.The procedure was completed with another of same device.No patient complications were reported.However, device analysis revealed that the device was fractured 25.5cm from the hub.It was further reported that the fracture was noted upon fully removing the device from the patient's body.

• 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: 12528450
• Report Number: 2134265-2021-12079
• Device Sequence Number: 17169385
• Product Code: KRA
• UDI-Device Identifier: 08714729839316
• UDI-Public: 08714729839316
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/24/2021

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: 03/03/2023
• Device Model Number: 80618
• Device Catalogue Number: 80618
• Device Lot Number: 0026904025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/03/2021
• Initial Report FDA Received Date: 09/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR