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

Model Number MV-MS175A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Anaphylactic Shock (1703)

Event Date 08/18/2020

Event Type  Injury  

Manufacturer Narrative

A search for non-conformance 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 was not returned to the manufacturer for evaluation.The cause of the event cannot be confirmed.No information suggesting a device malfunction was received by the manufacturer.

Event Description

It was reported that during preparation for an ia coil embolization procedure that involved the use of the microcatheter (along with medications and anesthesia), the patient developed an anaphylactic reaction.The procedure was discontinued.The patient's current condition is reported to be "favorable.".

• Brand Name: HEADWAY 17 MICROCATHETER
• Type of Device: PERCUTANEOUS CATHETER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• Manufacturer Contact: eva manus ; 35 enterprise drive; aliso viejo, CA 92656
• MDR Report Key: 10543697
• MDR Text Key: 207299210
• Report Number: 2032493-2020-00255
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 04987350609090
• UDI-Public: (01)04987350609090(11)200131(17)221231(10)20013158C
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K101542
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: MV-MS175A
• Device Lot Number: 20013158C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening