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

Model Number 101036CSSR-V

Device Problems Detachment Of Device Component (1104); Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2018

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 implant coil was noted to be stretched with no monofilament tie knot, and intermittent open gaps on the distal section.The attachment section of the pusher appeared to have a tie knot.The pusher was dissected to expose the attachment tether monofilament and check on its shape and rebound length.The attachment tether monofilament appeared to be within the heater coil section of the pusher, which is indicative of a low rebound length and low tensile value.Based on the available information and evaluation of the returned device, the complaint of a detached coil can be confirmed.The root cause cannot be determined; however, the device exhibits evidence that it was subjected to tensile forces that exceeded its strength specifications.

Event Description

It was reported that multiple attempts were made to implant the embolization coil; however, the coil was unable to be implanted.During withdrawal, the coil detached inside the microcatheter.The coil was removed in its entirety along with the microcatheter from the patient.There was no reported intervention or patient injury.The patient was reported to be doing well post procedure.

• Brand Name: MICROPLEX COSMOS
• 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: 7436404
• MDR Text Key: 106157462
• Report Number: 2032493-2018-00070
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00811425025857
• UDI-Public: (01)00811425025857(11)160325(17)210325(10)160325V2
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K093919
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/25/2021
• Device Model Number: 101036CSSR-V
• Device Lot Number: 160325V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2016
• 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: 28 YR
• Patient Weight: 50