MAUDE Adverse Event Report: MICROVENTION, INC. HEADWAY DUO MICROCATHETER

Model Number	MC162167S
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided.A review of the approved device history records indicated the lot met all release criteria.A lot history trending review was performed and there were no similar complaints for this lot number.The device was discarded at the user facility; therefore, a product analysis could not be performed.The root cause cannot be determined.
Event or Problem Description
It was reported that a microcatheter passed the pre-test; however, the proximal portion of the microcatheter broke during use.The entire microcatheter was removed in its entirety.There was no reported patient injury or intervention.The patient's current condition is reported to be fine.

• Brand Name: HEADWAY DUO MICROCATHETER
• Common Device Name: MICROCATHETER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 6830326
• Report Number: 2032493-2017-00219
• Device Sequence Number: 1522443
• Product Code: DQY
• UDI-Device Identifier: 00810170014413
• UDI-Public: (01)00810170014413(11)160824(17)190731(10)16082423
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K083343
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/04/2017

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: 07/31/2019
• Device Model Number: MC162167S
• Device Lot Number: 16082423
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2017
• Initial Report FDA Received Date: 08/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1