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

Model Number	29420
Medical Device Problem Codes	Difficult to Insert (1316); Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Analysis of the tip and shaft included microscopic and visual inspection.Inspection revealed an outer shaft separation located 18.7cm from the strain relief and the shaft stretched between the shaft fracture for 17.5 cm.Analysis of the rest of the device found no other damage or defect.The undamaged outer diameter (od) of the renegade hi-flo microcatheter was measured with a calibrated micrometer and met specification.The 4f hanako catheter was not returned for analysis.The reported difficulty advancing in a sheath was confirmed.Review of the product specification indicates the renegade hi-flo microcatheter is compatible with a catheter id (inner diameter) >.04.The reported information indicates the renegade hi-flo was used with a 4f/.05 catheter; therefore, there is no indication of a compatibility issue.The stretched catheter was confirmed, however; the insertion difficulty could not be replicated and clinical circumstances could not be replicated.
Event or Problem Description
Reportable based on device analysis completed on 20nov2020.It was reported that device stuck and stretched from hub towards the tip.The target lesion was located in the moderately tortuous artery.A 135/20 renegade hi-flo was selected for use.During procedure, it was noted that the device was stuck when crossing through the 4f non-boston scientific sheath.The device was removed without resistance and noted to have stretched from the hub 15cm towards the distal tip.The procedure was completed with a different device.No patient complications were reported.However, device analysis revealed outer shaft separation at 18.7cm from the strain relief.

• Brand Name: RENEGADE HI-FLO
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10936623
• Report Number: 2134265-2020-16726
• Device Sequence Number: 3489590
• Product Code: KRA
• UDI-Device Identifier: 08714729280644
• UDI-Public: 08714729280644
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140329
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/02/2020

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: 06/12/2021
• Device Model Number: 29420
• Device Catalogue Number: 29420
• Device Lot Number: 0022371026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2020
• Initial Report FDA Received Date: 12/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SHEATH: 4F HANAKO