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 Patient Involvement (2645)
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.The microcatheter was returned loaded in its dispenser coil package in the opened pouch.Visual inspection revealed that the microcatheter shaft had separated from its proximal shaft at approximately 2.0cm distal to the strain relief.The catheter was compressed on its proximal shaft at 36.0cm from its distal end also.Functional testing could not be performed due to the condition of the returned device.Information available indicated that the device could not be removed after flushing.The catheter was found to be jammed in the dispenser hoop; however, it could be removed after it was flushed.The device likely sustained damage during removal while preparing the product.The analyzed stretched, separated, and compressed catheter were likely caused by handling of the catheter during removal from the hoop dispenser.An assignable cause of handling was assigned to the observed damages.
Event or Problem Description
The microcatheter was returned for analysis and it was discovered that the outer shaft of the microcatheter had separated.There was no patient involvement.

• 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: 5991947
• Report Number: 0009616684-2016-00001
• Device Sequence Number: 71470
• 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