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

Model Number	29462
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/07/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that tip of the wire broke off.A 180cm/150cm renegade hi-flo fathom system was selected for use.During the procedure, it was noted that the tip of the wire broke off and remained in the catheter.The device was completely removed and no device fragments were left inside the patient.The wire was then replaced with another of the same size and completed the procedure.No complications reported and patient was fine.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The renegade catheter and guidewire are part of a kit.The renegade catheter was not returned.Analysis was completed on the guidewire only.The guidewire was inspected for damage.The device showed that the tip was separated.The separated tip was returned and measured approximately 11cm long.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.
Event or Problem Description
It was reported that tip of the wire broke off.A 180cm/150cm renegade hi-flo fathom system was selected for use.During the procedure, it was noted that the tip of the wire broke off and remained in the catheter.The device was completely removed and no device fragments were left inside the patient.The wire was then replaced with another of the same size and completed the procedure.No complications reported and patient was fine.

• 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
• MDR Report Key: 9255311
• Report Number: 2134265-2019-13123
• Device Sequence Number: 3763328
• Product Code: KRA
• UDI-Device Identifier: 08714729790884
• UDI-Public: 08714729790884
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K140329
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2019

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 Model Number: 29462
• Device Catalogue Number: 29462
• Device Lot Number: 0024028997
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Initial Date Received by Manufacturer: 10/09/2019
• Supplement Date Received by Manufacturer: 10/31/2019
• Initial Report FDA Received Date: 10/30/2019
• Supplement Report FDA Received Date: 11/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1