MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL NANO 1MM X 3CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number M0035431030

Device Problem Premature Activation (1484)

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

Event Date 12/04/2017

Event Type  Injury  

Manufacturer Narrative

The device is not available to the manufacturer.

Event Description

It was reported that the coil detached prematurely inside the microcatheter during manipulation.The coil was retrieved with a snare and the procedure was completed successfully.There were no reported clinical consequences to the patient.

Manufacturer Narrative

Manufacturing date ¿ added.Device evaluated by mfg ¿updated.Summary attached - updated.Expiration date - added.Product available to stryker ¿ updated.Returned to manufacturer on ¿updated.The device history record review confirms that the device met all material, assembly and performance specifications.The subject device was returned with a snare device.The coil delivery wire was not returned for analysis.The main coil was returned snared within a third party device.Visual inspection of the device revealed that the main coil was kinked, stretched and prematurely detached/separated due to a physical break at the detachment zone.No other anomalies were noted.Functional testing could not be performed due to the damaged condition of the returned coil.Information available indicated that resistance was observed during advancement of the coil in the microcatheter.It is likely that the main coil was damaged during use thus limiting the performance of the coil during the clinical procedure.Therefore, an assignable cause of operational context has been assigned to this investigation.

Event Description

It was reported that the coil detached prematurely inside the microcatheter during manipulation.The coil was retrieved with a snare and the procedure was completed successfully.There were no reported clinical consequences to the patient.

• Brand Name: TARGET HELICAL NANO 1MM X 3CM
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 7147190
• MDR Text Key: 95790225
• Report Number: 3008881809-2017-00537
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 04546540698018
• UDI-Public: (01)04546540698018(17)180731(10)18518013
• Combination Product (y/n): N
• PMA/PMN Number: K113412
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Model Number: M0035431030
• Device Catalogue Number: M0035431030
• Device Lot Number: 18518013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2015
• 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
• Treatment: EXCELSIOR MICROCATHETER(STRYKER)
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR