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

Model Number	29462
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on additional information received on 20jan2022.It was reported that the microcatheter was kinked and cracked.A 180cm /135cm renegade hi-flo fathom system was selected for use.Upon unpacking, it was noted that the microcatheter was hiascent.The procedure was completed with another of the same device.No complications reported and patient was stable post procedure.However , additional information revealed that the microcatheter has been cracked.Also, it was reported that the device was kinked and busted.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The device returned in a angiographic catheter.The device showed multiple fractures along the shaft that was protruding from the proximal end of the angiographic catheter.The shaft was not completely separated the inner liner was intact.No other damage could be confirmed as the device was stuck in the angiographic catheter.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.The complaint was confirmed for device stuck in another device and shaft damage.
Event or Problem Description
Reportable based on additional information received on 20jan2022.It was reported that the microcatheter was kinked and cracked.A 180cm /135cm renegade hi-flo fathom system was selected for use.Upon unpacking, it was noted that the microcatheter was hiascent.The procedure was completed with another of the same device.No complications reported and patient was stable post procedure.However, additional information revealed that the microcatheter has been cracked.Also, it was reported that the device was kinked and busted.

• Brand Name: RENEGADE HI-FLO FATHOM SYSTEM
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13497626
• Report Number: 2134265-2022-01110
• Device Sequence Number: 4779440
• Product Code: KRA
• UDI-Device Identifier: 08714729790860
• UDI-Public: 08714729790860
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2022

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: 03/22/2024
• Device Model Number: 29462
• Device Catalogue Number: 29462
• Device Lot Number: 0027017295
• 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: 01/14/2022
• Supplement Date Received by Manufacturer: 02/18/2022
• Initial Report FDA Received Date: 02/09/2022
• Supplement Report FDA Received Date: 03/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2021
• 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
• Patient Age: 58 YR
• Patient Sex: Male