MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 4MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035474060
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/02/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During the coil embolization procedure, it was reported that the physician thought the first coil (subject device) was smaller than the size on the label.However, he still detached the coil.Then the physician advanced the second coil and big resistance was felt in the microcatheter.So he withdrew the second coil, but the first coil came out with the second coil together and the first coil was found stretched.The procedure was completed with other coils.No clinical consequences reported to the patient.
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.During the analysis of the returned device, it was revealed that the main coil was kinked, stretched and the main coil suture was damaged.So it was impossible to measure the length of the coil; therefore the cause of the reported main coil incorrect dimension could not be determined.In addition, the delivery wire was revealed kinked due to handling.No functional test could be performed on the returned device.Based on the information currently available and the device inspection, it is most likely that the damage noted on the main coil during analysis and the reported event were due to the interaction with another coil inside the catheter during the clinical procedure.Therefore, an assignable cause of ¿operational context caused¿ will be assigned to the analyzed issue and reported event, as the issue is associated with a product that meets the design and manufacture specifications and was used in according with the dfu (direction for use) but due to procedural and/or anatomical factors during use, the device performance was limited.
Event or Problem Description
During the coil embolization procedure, it was reported that the physician thought the first coil (subject device) was smaller than the size on the label.However, he still detached the coil.Then the physician advanced the second coil and big resistance was felt in the microcatheter.So he withdrew the second coil, but the first coil came out with the second coil together and the first coil was found stretched.The procedure was completed with other coils.No clinical consequences reported to the patient.

• Brand Name: TARGET 360 SOFT 4MM X 6CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7473166
• Report Number: 3008881809-2018-00192
• Device Sequence Number: 1216007
• Product Code: HCG
• UDI-Device Identifier: 04546540676450
• UDI-Public: (01)04546540676450(17)190430(10)18988965
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: M0035474060
• Device Catalogue Number: M0035474060
• Device Lot Number: 18988965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2018
• Initial Date Received by Manufacturer: 04/02/2018
• Supplement Date Received by Manufacturer: 06/06/2018
• Initial Report FDA Received Date: 04/30/2018
• Supplement Report FDA Received Date: 06/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 75