MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 3MM X 4CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number M0035423040

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2014

Event Type  malfunction  

Event Description

It was reported that the coil (subject device) detached but the tail of the coil was hanging out of the neck of the aneurysm.No other information is available.

Event Description

It was reported that the coil (subject device) detached, but the microcatheter ¿¿happened to grab the tail of the coil¿¿ and pull it back into the microcatheter and into the parent vessel.The physician was able to insert most of the coil back into the aneurysm safely without a tail in the parent artery.Aspirin was given.The patient was not impacted and was stable at the end of the case.

Manufacturer Narrative

The subject device remains implanted.

Manufacturer Narrative

The subject device was not returned; therefore, an analysis could not be performed.The device history record review confirms that the device met all material, assembly and performance specifications.Based on the investigation and information available, this issue is associated with a product that meets design and manufacturing specifications, and was used in according to the directions for use, but device performance was limited due to procedural factors/operational context.

• Brand Name: TARGET 360 ULTRA 3MM X 4CM
• 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: 4346245
• MDR Text Key: 5203529
• Report Number: 3008853977-2014-00414
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102672
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/10/2014

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: 08/05/2016
• Device Catalogue Number: M0035423040
• Device Lot Number: 17162920
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2015
• Initial Date FDA Received: 12/19/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2013
• 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
• Treatment: EXCELSIOR SL10 MICROCATHETER (STRYKER)