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

Model Number 100102HS-V-A-CN

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/29/2016

Event Type  Injury  

Manufacturer Narrative

The delivery pusher was returned with the introducer and dispenser coil.The implant coil was not returned.The resistance of the system was noted to be 46.2 ohms and the unit passed the 4-way check with the v-grip.The hypotube was noted to be kinked at the laser weld connector.There was evidence of glue on the distal body coil.The monofilament was noted to be completely necked down and had a long tail.The monofilament was noted to be stretched and completely necked down, likely due to issues with retracting the stuck implant coil from the microcatheter.The implant, being small, may have gotten stuck in the hub of the microcatheter, causing resistance during advancement, and further manipulation may have caused the glue at the tie knot locations to spread over the pusher body coil.The stuck implant may have gotten stretched and then detached prematurely while pulling the pusher back from the microcatheter, as evidenced by the stretched monofilament.Based on the information provided and the product evaluation, the reported detachment can be confirmed; however, the root cause cannot be determined because the conditions of use cannot be recreated during bench testing.

Event Description

It was reported that during a coil embolization treatment, the coil did not advance in the microcatheter, then the coil unexpectedly detached in the microcatheter.Pliers were used to remove the coil.The entire coil was removed from the patient.There was no reported patient injury.The current patient's status is reported to be "fine.".

• Brand Name: MICROPLEX HYPERSOFT HELICAL
• Type of Device: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• Manufacturer Contact: debby callahan ; 1311 valencia avenue; tustin, CA 92780 ; 7142478000
• MDR Report Key: 6394116
• MDR Text Key: 69557802
• Report Number: 2032493-2017-00059
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00811425021088
• UDI-Public: (01)00811425021088(11)161003(17)210930(10)161003E2
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 02/07/2017

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
• Device Operator: Physician
• Device Expiration Date: 09/30/2021
• Device Model Number: 100102HS-V-A-CN
• Device Lot Number: 161003E2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2017
• Initial Date FDA Received: 03/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2016
• 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 Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 57