MAUDE Adverse Event Report: MICROVENTION, INC. HEADWAY DUO MICROCATHETER; DIAGNOSTIC INTRAVASCULAR CATHETER

Model Number	MC162156S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device has not been received by the manufacturer for evaluation.
Event or Problem Description
It was reported that treatment was being performed for a large avm.After the microcatheter (headway-duo) was positioned in the posterior circulation, the microcatheter lost position.During the attempt to withdraw the microcatheter back, the microcatheter detached completely inside the guide catheter.A balloon catheter was used to hold the detached segment to the guide catheter to remove it from the patient.There was no reported patient injury.
Additional Manufacturer Narrative
Visual investigation of the returned device found that the device was separated 38cm from the proximal end.Close up images of both the proximal and distal sides of the separation were taken along with magnification x1500 photos of the broken coil and braid.For comparison, other duo samples were obtained and were separated in the following ways: tensile pulled, cut with wire cutter, cut with scissors, cut with razor blade.Images were taken of these samples were compared to images of the returned device in an effort to determine how the unit failed.It was able to be determined that the unit did not experience a tensile failure.It appears that the sample was cut.The investigation of the returned headway found it to be severed 38cm from the proximal end.The break appears to be the result of shear/cutting force rather than tensile force based on profile of the break and comparative testing.The physical evaluation of the device could not identify the conditions or circumstances that led to this cut, but the cut would have had to occur while the headway duo was out of the guide catheter.

• Brand Name: HEADWAY DUO MICROCATHETER
• Common Device Name: DIAGNOSTIC INTRAVASCULAR CATHETER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• MDR Report Key: 10177032
• Report Number: 2032493-2020-00136
• Device Sequence Number: 17022808
• Product Code: DQO
• UDI-Device Identifier: 00810170014345
• UDI-Public: (01)00810170014345(11)191119(17)221031(10)19111911P
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120917
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 10/31/2022
• Device Model Number: MC162156S
• Device Catalogue Number: MC162156S
• Device Lot Number: 19111911P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2020
• Initial Date Received by Manufacturer: 05/20/2020
• Supplement Date Received by Manufacturer: 06/22/2020
• Initial Report FDA Received Date: 06/19/2020
• Supplement Report FDA Received Date: 07/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention