MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 2 MM X 4 CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number M0035442040

Device Problems Detachment Of Device Component (1104); Sticking (1597); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/04/2016

Event Type  malfunction  

Event Description

It was reported that when the coil (the subject device) was advanced into the microcatheter, resistance was felt and it was stuck.Therefore, both the coil and the microcatheter were retrieved.The coil detached inside the microcatheter when an attempt was made to pull it out.The procedure was completely successfully with a new coil and microcatheter.There were no clinical consequences to the patient.

Manufacturer Narrative

The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The coil was returned within the microcatheter.Analysis of the coil revealed that the main coil was tangled, kinked, and stretched.The coil appeared to have broken off at the proximal side of the delivery wire detachment section.Information available indicated that the coil was confirmed to be in good condition prior to use.The extensive damage observed is indicative of excessive force being applied during the procedure though this cannot be conclusively determined.Based on the information available it is probable that procedural factors may have limited the performance of the coil resulting in the reported issue and damages observed.Therefore, an assignable cause of operational context was assigned to this investigation.

Event Description

It was reported that when the coil (the subject device) was advanced into the microcatheter, resistance was felt and it was stuck.Therefore, both the coil and the microcatheter were retrieved.The coil detached inside the microcatheter when an attempt was made to pull it out.The procedure was completely successfully with a new coil and microcatheter.There were no clinical consequences to the patient.

• Brand Name: TARGET 360 NANO 2 MM X 4 CM
• 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: sanda dracic ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 5405549
• MDR Text Key: 37720368
• Report Number: 3008853977-2016-00030
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• PMA/PMN Number: K113412
• 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: 01/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/09/2018
• Device Catalogue Number: M0035442040
• Device Lot Number: 18489896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2015
• 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