MAUDE Adverse Event Report: MICROVENTION, INC. COSMOS-18-AV; EMBOLIZATION COIL

Model Number 181243CS-V-A

Device Problems Detachment Of Device Component (1104); Stretched (1601); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/07/2016

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.The device was returned to the manufacturer for evaluation.The implant coil was not attached to the delivery pusher.Visual inspection revealed the pusher body coil was normal and the heater coil was compressed.The monofilament that holds the implant to the delivery pusher had evidence of stretching.Based on the product evaluation and the reported complaint details, the root cause could not be determined; however, the condition of the returned device is consistent with the device being exposed to a force that exceeded the maximum tensile specification.(b)(4).

Event Description

It was reported in (b)(6) that there was resistance while deploying coil.The physician decided to remove the coil and while pulling the delivery wire back, the coil got detached inside the microcatheter.The microcatheter was removed.No patient injury was reported.

• Brand Name: COSMOS-18-AV
• Type of Device: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• Manufacturer Contact: eva manus ; 1311 valencia avenue; tustin, CA 92780 ; 7142478000
• MDR Report Key: 6042775
• MDR Text Key: 57921379
• Report Number: 2032493-2016-00253
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K102365
• 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: 09/19/2016

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: 06/30/2020
• Device Model Number: 181243CS-V-A
• Device Lot Number: 150603V7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2016
• Initial Date FDA Received: 10/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2015
• 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: 53 YR
• Patient Weight: 62