MAUDE Adverse Event Report: MICROVENTION, INC. HEADWAY 17 MICROCATHETER

Model Number	MC172150SX
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/06/2017
Type of Reportable Event	Serious Injury
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 has not yet been returned for evaluation.The investigation is currently underway.
Event or Problem Description
It was reported that during advancement of a stent through the microcatheter, the physician "felt a crunch" and the microcatheter appeared to have broken approximately 50cm from the hub.The stent was removed along with the proximal portion of the microcatheter.The distal segment of the microcatheter was trapped and retrieved with a scepter balloon.There was no reported patient injury.

• Brand Name: HEADWAY 17 MICROCATHETER
• Common Device Name: MICROCATHETER
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 6708898
• Report Number: 2032493-2017-00167
• Device Sequence Number: 19073660
• Product Code: DQY
• UDI-Device Identifier: 00810170013751
• UDI-Public: (01)00810170013751(11)161207(17)191130(10)161207ZC1
• Combination Product (Y/N): N
• 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): 06/12/2017

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: Physician
• Device Expiration Date: 11/30/2019
• Device Model Number: MC172150SX
• Device Lot Number: 161207ZC1
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2017
• Initial Report FDA Received Date: 07/12/2017
• 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
• Patient Age: 62 YR
• Patient Weight: 43