MAUDE Adverse Event Report: MICROVENTION, INC. MICROPLEX HELICAL SOFT 10-AV; EMBOLIZATION COIL

Model Number 100208HC-S-V-A1-CN

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/14/2016

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided.A review of the approved device history records indicated that 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 to the manufacturer for evaluation.The investigation is currently ongoing.The submission of this report or related information to the fda, and its release by fda, does not reflect a conclusion by the party submitting this report or the fda that the report or related information is an admission that the manufacturer, their employees, or the device caused or contributed to the reportable event.

Event Description

It was reported that during advancement of an embolization coil, resistance was encountered at the proximal end of the microcatheter.After removal, the coil was found to have unexpectedly detached in the microcatheter.Both segments of the coil were removed in their entirety with the microcatheter.There was no reported patient injury.The current patient's status is reported to be fine.

Manufacturer Narrative

The device was received for evaluation.The implant coil was stuck inside the microcatheter and had to be retrieved after flushing, then finally cutting the microcatheter.The coil was noted to be completely stretched and damaged and could be only partly retrieved, which included the proximal section, as the marker band was present.Dissection of the microcatheter in the area of the stuck coil revealed that the coil circumferencing the ptfe liner was broken, which may have caused difficulties during advancing the implant coil inside the microcatheter.This may have further caused the implant to get stuck inside the microcatheter, with only the pusher being retracted back causing the break.The monofilament had rebounded inside the pusher body coil, and was noted to have a flat severed end.There was no evidence of thermal damage to the black pet covering the heater coil.Both lead wires were noted to be broken based on the investigation and provided information, the reported complaint of a broken coil can be confirmed.The force exerted during the coil winding process, with no evidence of thermal damage, is consistent with the coil being subjected to force exceeding the monofilament tensile strength.

• Brand Name: MICROPLEX HELICAL SOFT 10-AV
• 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: 6434597
• MDR Text Key: 70889265
• Report Number: 2032493-2017-00073
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00812636024509
• UDI-Public: (01)00812636024509(11)161018(17)210930(10)161018W2
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K131948
• 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: 02/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/30/2021
• Device Model Number: 100208HC-S-V-A1-CN
• Device Lot Number: 161018W2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/23/2017
• Initial Date FDA Received: 03/25/2017
• Supplement Dates Manufacturer Received: 02/23/2017
• Supplement Dates FDA Received: 10/27/2017
• 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 Age: 54 YR
• Patient Weight: 64