MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 6MM X15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number M0035476150

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/15/2014

Event Type  malfunction  

Event Description

It was reported that during the unpacking and preparation of the device it was noted that the outer shaft was broken and the coil could not be pushed properly.There was no contact with the patient and the procedure was successfully completed with other coils.No other information was provided.

Manufacturer Narrative

The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.Visual and microscopic inspection of the returned device found the main coil was stretched.The main junction was kinked and main coil distal to the main junction was stretched.No anomalies were noted to the introducer sheath.The main coil could not be advanced through the introducer sheath.There were no breaks in the main coil or delivery wire, as the delivery wire was found to be intact, though the proximal contact was kinked.The proximal contact is a subcomponent located at the proximal end of the pusher wire that works in conjunction with the inzone to complete a circuit cycle during the detachment process.The proximal contact remains outside the patient at all times during the procedure and never comes in contact with the patient.Based on the device investigation, the reported event was not confirmed.The manufacturer has reviewed all information and determined this event no longer meets the requirement of a reportable event for the device in question.

Event Description

It was reported that during the unpacking and preparation of the device it was noted that the outer shaft was broken and the coil could not be pushed properly.There was no contact with the patient and the procedure was successfully completed with other coils.No other information was provided.

Manufacturer Narrative

The subject device has not been returned.

• Brand Name: TARGET 360 SOFT 6MM X15CM
• 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: alyson harris ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 4346543
• MDR Text Key: 5492835
• Report Number: 3008853977-2014-00417
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: HU
• PMA/PMN Number: K102672
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/15/2014

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: Health Professional
• Device Expiration Date: 03/31/2016
• Device Catalogue Number: M0035476150
• Device Lot Number: 15972067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2015
• Initial Date FDA Received: 12/19/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2013
• 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