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

Model Number	M001394101300
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported the catheter broke.A 130cm truselect was selected for an embolization procedure within abdominal area varices.Embolization was performed with a non-boston scientific copolymer.The copolymer seemed to have settled around the truselect catheter.During removal of the catheter, the catheter stretched and broke.The detached fragment remained within the patient.There were no further patient complications and the embolization procedure was complete.The patient was ok post procedure.
Additional Manufacturer Narrative
A2 - age at time of event: 18 years or older.Device eval by mfr: returned product consisted of a truselect microcatheter, without the tip.Analysis of the tip, shaft and hub/strain relief included microscopic and visual inspection.Inspection revealed a complete separation in the shaft with the tip not returned, and the distal end of the shaft was stretched for 26.3cm.Inspection of the rest of the device found no other damage or defects.Due to the extreme shaft stretching, an accurate length of the device could not be obtained.
Event or Problem Description
It was reported the catheter broke.A 130cm truselect was selected for an embolization procedure within abdominal area varices.Embolization was performed with a non-boston scientific copolymer.The copolymer seemed to have settled around the truselect catheter.During removal of the catheter, the catheter stretched and broke.The detached fragment remained within the patient.There were no further patient complications and the embolization procedure was complete.The patient was ok post procedure.

• Brand Name: TRUSELECT
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11116847
• Report Number: 2134265-2020-18754
• Device Sequence Number: 4050806
• Product Code: KRA
• UDI-Device Identifier: 08714729976615
• UDI-Public: 08714729976615
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K201792
• 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,Followup
• Report Date (Section B): 03/09/2021

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: 10/09/2021
• Device Model Number: M001394101300
• Device Lot Number: 0026157272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2021
• Initial Date Received by Manufacturer: 12/17/2020
• Supplement Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 01/05/2021
• Supplement Report FDA Received Date: 03/09/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ONYX 18; ONYX 18
• Outcome Attributed to Adverse Event: Other