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

Model Number	80618
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that microcatheter became occluded and the outer layer ruptured under pressure.This direxion microcatheter was selected for use for a pelvic embolization procedure.During the procedure, while inside the patient the catheter became blocked and the outer layer ruptured under pressure.The rupture made the catheter difficult to remove, however they were able to remove the entire microcatheter and probe assembly without sequela.
Event or Problem Description
It was reported that microcatheter became occluded and the outer layer ruptured under pressure.This direxion microcatheter was selected for use for a pelvic embolization procedure.During the procedure, while inside the patient the catheter became blocked and the outer layer ruptured under pressure.The rupture made the catheter difficult to remove, however they were able to remove the entire microcatheter and probe assembly without sequela.
Additional Manufacturer Narrative
Device eval by manufacturer: returned product consisted of a direxion microcatheter from batch 28697343.The device shaft was microscopically analyzed which revealed multiple bends and two fractures located 48 cm and 51 cm from the hub.Further inspection found stretching located 48 cm to 64.5 cm from the hub.A test guidewire was attempted to be inserted into the lumen; however, the wire would not transcend past the stretched area of the device.

• 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: 14978219
• Report Number: 2124215-2022-23872
• Device Sequence Number: 5831409
• Product Code: KRA
• UDI-Device Identifier: 08714729839422
• UDI-Public: 08714729839422
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2022

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: 01/18/2024
• Device Model Number: 80618
• Device Catalogue Number: 80618
• Device Lot Number: 0028697343
• 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: 06/29/2022
• Supplement Date Received by Manufacturer: 09/01/2022
• Initial Report FDA Received Date: 07/11/2022
• Supplement Report FDA Received Date: 09/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown