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

Model Number	80618
Medical Device Problem Codes	Break (1069); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a break occurred resulting in additional intervention.A direxion catheter was selected for use to treat an endoleak in the lumbar artery.During withdrawal, the catheter was difficult to remove and ripped.It took one and a half hours to retrieve the broken part of the catheter from the patient.The patient may come back and get treated again.There were no patient complications.
Additional Manufacturer Narrative
Device evaluated by mfr: the direxion microcatheter was returned to boston scientific for analysis.The device shaft was microscopically analyzed for any damage.The device showed multiple fractures and bends located on the shaft.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.
Event or Problem Description
It was reported that a break occurred resulting in additional intervention.A direxion catheter was selected for use to treat an endoleak in the lumbar artery.During withdrawal, the catheter was difficult to remove and ripped.It took one and a half hours to retrieve the broken part of the catheter from the patient.The patient may come back and get treated again.There were no patient complications.

• Brand Name: DIREXION
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15293876
• Report Number: 2124215-2022-31840
• Device Sequence Number: 12321405
• Product Code: KRA
• UDI-Device Identifier: 08714729839354
• UDI-Public: 08714729839354
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/14/2023
• Device Model Number: 80618
• Device Catalogue Number: 80618
• Device Lot Number: 0028553496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2022
• Supplement Date Received by Manufacturer: 09/16/2022
• Initial Report FDA Received Date: 08/25/2022
• Supplement Report FDA Received Date: 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male