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

Model Number	29462
Medical Device Problem Codes	Difficult to Remove (1528); Stretched (1601); Detachment of Device or Device Component (2907); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the microcatheter pulled apart and the outer coating split.A fathom 16 180cm renhf 150cm 10 preload renegade hi flo microcatheter system was selected for use.During the procedure, it was noted that the device was getting stuck within the diagnostic catheter.A tight push was needed, and the device was able to be advanced for treatment.When the device was pulled out and checked, the microcatheter pulled apart and stretched.The coating layer split and separated.The device was removed from the patient intact, and the procedure was completed.The patient was not harmed, and no complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.The hub and the part of the shaft that was visible was inspected for damage.The renegade device was stuck in the angiographic catheter.A touhey was attached to a 4fr.038 angio catheter.The shaft of the renegade was kinked 12.5cm from the tip and protruding from the angio catheter 12.5cm.There was stretching located 5cm, 8.5cm, 18cm, and 23cm from the hub.No fractures were noticed on the shaft.The coating issue the customer stated is most likely the shaft damage that was confirmed, no coating issues were confirmed.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.The complaint was confirmed for inserting issues and shaft damage.
Event or Problem Description
It was reported that the microcatheter pulled apart and the outer coating split.A fathom 16 180cm renhf 150cm 10 preload renegade hi flo microcatheter system was selected for use.During the procedure, it was noted that the device was getting stuck within the diagnostic catheter.A tight push was needed, and the device was able to be advanced for treatment.When the device was pulled out and checked, the microcatheter pulled apart and stretched.The coating layer split and separated.The device was removed from the patient intact, and the procedure was completed.The patient was not harmed, and no complications were reported.

• Brand Name: RENEGADE HI-FLO FATHOM SYSTEM
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; 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: 17957064
• Report Number: 2124215-2023-56035
• Device Sequence Number: 15212686
• Product Code: KRA
• UDI-Device Identifier: 08714729790877
• UDI-Public: 08714729790877
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K140329
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2023

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: 01/03/2026
• Device Model Number: 29462
• Device Catalogue Number: 29462
• Device Lot Number: 0030787255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/28/2023
• Supplement Date Received by Manufacturer: 10/24/2023
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 11/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DIAGNOSTIC CATHETER-4FR 125CM CORDIS VERT.; DIAGNOSTIC CATHETER-4FR 125CM CORDIS VERT.
• Patient Sex: Unknown