MAUDE Adverse Event Report: REFLOW MEDICAL, INC. WINGMAN 35 CROSSING CATHETER; SUPPORT CATHETER

Model Number	WGM35065US
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient injury or impact to the patient as a result of the tip separation.The device history records were reviewed with special attention to components, subassemblies and in-house manufacturing processes.This lot met all acceptance criteria for release.The investigation performed to date confirmed tip separation.The root cause of the tip failure could not be determined based on the available information.Further investigation is warranted and in process.
Event or Problem Description
During device preparation, per the instructions for use, the physician ran their fingers over the catheter and the tip detached.Device had no patient contact.

• Brand Name: WINGMAN 35 CROSSING CATHETER
• Common Device Name: SUPPORT CATHETER
• Manufacturer (Section D): REFLOW MEDICAL, INC.; 1003 calle sombra; san clemente CA 92673
• MDR Report Key: 6425329
• Report Number: 3008789872-2017-00001
• Device Sequence Number: 1102262
• Product Code: DQY
• UDI-Device Identifier: 00856492005180
• UDI-Public: 00856492005180
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K141547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 03/08/2017

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: Physician
• Device Expiration Date: 02/17/2019
• Device Model Number: WGM35065US
• Device Catalogue Number: WGM35065US
• Device Lot Number: 1602164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2017
• Initial Report FDA Received Date: 03/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3008789872_03222017_001R
• Patient Sequence Number: 1