MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 4MM X 10CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035474100
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is not available.
Event or Problem Description
It was reported that during the coil embolization procedure, the coil could not be detached after three attempts.So the physician decided to remove coil.However, the coil was detached prematurely inside the microcatheter hub during removal.No clinical consequences reported to the patient.
Event or Problem Description
It was reported that during the coil embolization procedure, the coil could not be detached after three attempts.So the physician decided to remove coil.However, the coil was detached prematurely inside the microcatheter hub during removal.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 prematurely detached inside the patient.In addition, the coil delivery wire was kinked due to handling damage.In the case of this complaint, it is most likely that anatomical or procedural factors resulted in the coil kinked/stretched and eventually detached when trying to remove.This complaint appears to be associated with a product that met the design and manufacturing specifications and was used in accordance with the dfu (direction for use), but performance was limited due to procedural factors during use.Therefore, a probable cause of procedural factors will be assigned to the reported and analyzed defects of the main coil.

• Brand Name: TARGET 360 SOFT 4MM X 10CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 9142919
• Report Number: 3008881809-2019-00297
• Device Sequence Number: 16600567
• Product Code: HCG
• UDI-Device Identifier: 07613252192756
• UDI-Public: 07613252192756
• Combination Product (Y/N): N
• Initial Reporter Country: SE
• 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): 12/17/2019

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: 03/31/2022
• Device Catalogue Number: M0035474100
• Device Lot Number: 21335495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2019
• Initial Date Received by Manufacturer: 09/11/2019
• Supplement Date Received by Manufacturer: 11/26/2019
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 12/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MICROCATHETER (UNKNOWN MANUFACTURER)