MAUDE Adverse Event Report: MICROVENTION, INC. MICROPLEX HYPERSOFT HELICAL; EMBOLIZATION COIL

Model Number 100154HS-V-A-CN

Device Problems Detachment Of Device Component (1104); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/17/2017

Event Type  malfunction  

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 Description

It was reported that an embolization coil did not advance in the middle of the microcatheter, then the coil unexpectedly detached in the microcatheter.Both segments of the coil were removed from the patient.There was no reported intervention or patient injury.The patient's status is reported to be fine.

Manufacturer Narrative

The device was returned for evaluation; however, the microcatheter was not returned for analysis.The implant coil was noted to be detached from the pusher, and the proximal end was stretched and damage at the tie knot section.The lead wires were noted to be separate from the core wire.The striations on the monofilament body confirms a tensile pull.The specific root cause of this complaint is unknown, although the device exhibits evidence that the monofilament was subjected to tensile forces that exceeded its strength specifications.

• Brand Name: MICROPLEX HYPERSOFT HELICAL
• Type of Device: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• Manufacturer Contact: debby callahan ; 35 enterprise drive; aliso viejo, CA 92656
• MDR Report Key: 6819648
• MDR Text Key: 83632025
• Report Number: 2032493-2017-00210
• Device Sequence Number: 1
• Product Code: HGC
• UDI-Device Identifier: 00810170019425
• UDI-Public: (01)00810170019425(11)150923(17)200930(10)150923E2
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K132952
• 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,Followup
• Report Date: 07/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/30/2020
• Device Model Number: 100154HS-V-A-CN
• Device Lot Number: 150923E2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2015
• 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 Age: 65 YR
• Patient Weight: 65