MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINN NEURO RENEGADE HI FLO 150/10; CATHETER, CONTINUOUS FLUSH

Catalog Number	M003182900US0
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/22/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.Visual inspection revealed that the microcatheter was compressed at 49.0cm distal to the strain relief, separated on its distal shaft and the distal tip was ripped off.The distal tip marker was not returned with the catheter.The microcatheter was kinked, compressed and deformed under the strain relief and just distal to the strain relief.Functional testing could not be performed due to the condition of the returned device.A 0.016 inch mandrel was advanced in the proximal end of the catheter and lot of friction was experienced.The cause for the catheter kinked, shaft flat/crushed, shaft deformed, and catheter friction could not be definitively determined because these were not previously reported.Information available indicated that the reported issue was observed during tip shaping.It is probable that the ripped off catheter tip likely occured during the tip shaping.It is likely that holding the device too close and/or to the steam source contributed to the reported issue.Per the device dfu: "shape microcatheter by holding mandrel/microcatheter assembly no closer than 2.54 cm (1 in) from steam source for approximately 10 seconds.Do not position microcatheter closer than 2.54 cm (1 in) from the steam source.Damage to the microcatheter may result." based on the information available, an assignable cause of use error was assigned to this event.
Event or Problem Description
The microcatheter was returned for analysis and it was discovered that the catheter distal tip was ripped off.There were no consequences to the patient.

• Brand Name: NEURO RENEGADE HI FLO 150/10
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC - MINN; one scimed place; maple grove MN 55311
• MDR Report Key: 5991945
• Report Number: 0009616684-2016-00002
• Device Sequence Number: 11222026
• Product Code: KRA
• UDI-Device Identifier: 08714729767510
• UDI-Public: (01)08714729767510(17)190131(10)18872347
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K000177
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/23/2016

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: 01/31/2019
• Device Catalogue Number: M003182900US0
• Device Lot Number: 18872347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2016
• Initial Report FDA Received Date: 09/30/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1