MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 6MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number M0036126200

Device Problem Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/14/2017

Event Type  malfunction  

Manufacturer Narrative

The device history record review confirms that the device met all material, assembly and performance specifications.The returned main coil was noted to be kinked and physically broken at the detachment zone.The delivery wire was not returned.Visual examination of the returned device revealed that the main coil was prematurely separated due to a break at the detachment zone; it was also observed that procedural fluid was noted on the main coil.It is probable that the device was damaged during the clinical procedure causing the observed break at the detachment zone.Therefore, an assignable cause of operational context has been assigned to the observed damages.

Event Description

The analysis of the returned product revealed that the main coil (subject device) was prematurely separated.There was no clinical consequences to the patient.

• Brand Name: TARGET XL 360 SOFT 6MM X 20CM
• 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: 7265823
• MDR Text Key: 100004978
• Report Number: 3008881809-2018-00074
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• PMA/PMN Number: K153658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: M0036126200
• Device Lot Number: 19912747
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2017
• 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