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

Model Number 29462

Device Problems Fracture (1260); Difficult to Remove (1528); Difficult to Advance (2920)

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

Event Date 11/02/2023

Event Type  malfunction  

Event Description

It was reported that the mid shaft of the device was fractured.A renegade hi-flo fathom system was selected for use.During advancing, the physician felt resistance when manipulating the microcatheter so the physician tried to retract it, but it would not retract more than about 10 cm.When the base catheter and the microcatheter were removed from the patient, it was noted that the mid shaft of the microcatheter was fractured.The detached portion of the device was removed from the body and no device fragments were left inside the body.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: the complaint device was received for product analysis.The device was visually and microscopically inspected for damage.The renegade device showed 3 areas of damage.One fracture located 26.9cm, stretching of the shaft located 30cm from the hub and 1 stretched and fractured area located 34.3cm from the hub.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.The complaint was confirmed for advancing issues and shaft damage.No other issues were identified during the product analysis.

Event Description

It was reported that the mid shaft of the device was fractured.A renegade hi-flo fathom system was selected for use.During advancing, the physician felt resistance when manipulating the microcatheter so the physician tried to retract it, but it would not retract more than about 10 cm.When the base catheter and the microcatheter were removed from the patient, it was noted that the mid shaft of the microcatheter was fractured.The detached portion of the device was removed from the body and no device fragments were left inside the body.No patient complications were reported.

• Brand Name: RENEGADE HI-FLO FATHOM SYSTEM
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18161738
• MDR Text Key: 328422785
• Report Number: 2124215-2023-63503
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 08714729790860
• UDI-Public: 08714729790860
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140329
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 29462
• Device Catalogue Number: 29462
• Device Lot Number: 0031696509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1