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

Model Number 80619

Device Problems Fracture (1260); Obstruction of Flow (2423); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/29/2022

Event Type  malfunction  

Event Description

It was reported that a shaft break occurred.A direxion hi-flo was selected for a uterine fibroid embolization procedure.While injecting beadblock, the catheter clogged several times.Intermittent flushing was performed to resolve the clogging.During removal from the patient, the physician noticed that the outer shaft was broken and detached from the inner shaft.There had not been a lot of torquing of the catheter by the interventional radiologist.There were no patient complications, and the procedure was completed successfully.

Event Description

It was reported that a shaft break occurred.A direxion hi-flo was selected for a uterine fibroid embolization procedure.While injecting beadblock, the catheter clogged several times.Intermittent flushing was performed to resolve the clogging.During removal from the patient, the physician noticed that the outer shaft was broken and detached from the inner shaft.There had not been a lot of torquing of the catheter by the interventional radiologist.There were no patient complications, and the procedure was completed successfully.It was further reported that 3 syringes of beadblock mixed with contract were delivered using the microcatheter.There was no resistance or friction experienced during removal of the catheter.The anatomy was mildly tortuous.The patient status was okay post procedure.

Manufacturer Narrative

Device evaluated by mfr: the direxion microcatheter was returned to boston scientific for analysis.The device shaft was visually and microscopically analyzed for any damage.The devices shaft showed a fracture located 40cm from the hub.The device was not completely separated the inner liner was still attached.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.

Event Description

It was reported that a shaft break occurred.A direxion hi-flo was selected for a uterine fibroid embolization procedure.While injecting beadblock, the catheter clogged several times.Intermittent flushing was performed to resolve the clogging.During removal from the patient, the physician noticed that the outer shaft was broken and detached from the inner shaft.There had not been a lot of torquing of the catheter by the interventional radiologist.There were no patient complications, and the procedure was completed successfully.It was further reported that 3 syringes of beadblock mixed with contract were delivered using the microcatheter.There was no resistance or friction experienced during removal of the catheter.The anatomy was mildly tortuous.The patient status was okay post procedure.

Manufacturer Narrative

B5: describe event or problem: additional information.

• Brand Name: DIREXION HI-FLO
• Type of Device: 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: 15624247
• MDR Text Key: 304689399
• Report Number: 2124215-2022-42017
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K142259
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/22/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2024
• Device Model Number: 80619
• Device Catalogue Number: 80619
• Device Lot Number: 0028895551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2022
• Initial Date FDA Received: 10/18/2022
• Supplement Dates Manufacturer Received: 10/18/2022; 11/29/2022
• Supplement Dates FDA Received: 11/09/2022; 12/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1