MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 2.5MM X 4CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035422540
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device not returned.
Event or Problem Description
It was reported that during the procedure, the subject coil was stuck in the distal part of the microcatheter.The operator had to cut the hub of the microcatheter to remove the coil with a snare device.The coil was noted to be stretched once removed from the patent¿s anatomy.No clinical consequences reported due to this event.
Additional Manufacturer Narrative
D4: expiration date: added.D10/h3: product available to stryker: updated.H4: manufacturing date: added.H3: device evaluated by mfg: updated.H3: summary attached: updated.The electronic device history record (edhr) review confirms that the device met all material, assembly and performance specifications.The reported event is covered in the direction for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.The device was returned for analysis, and coil was found stretched and jammed.In the case of this complaint it is most likely that the main coil stretched during coil advancement against friction and coil jammed due to the anatomy being very tortuous.This complaint appears to be associated with a product that met stryker and design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use; therefore, an assignable cause of procedural factors was assigned to the as reported and analyzed issues coil in catheter friction, patient medical or surgical intervention required, main coil stretched and main coil jammed.
Event or Problem Description
It was reported that during the procedure, the subject coil was stuck in the distal part of the microcatheter.The operator had to cut the hub of the microcatheter to remove the coil with a snare device.The coil was noted to be stretched once removed from the patent¿s anatomy.No clinical consequences reported due to this event.

• Brand Name: TARGET 360 ULTRA 2.5MM X 4CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 9274575
• Report Number: 3008881809-2019-00332
• Device Sequence Number: 127742
• Product Code: HCG
• UDI-Device Identifier: 04546540675866
• UDI-Public: 04546540675866
• Combination Product (Y/N): N
• 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): 01/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/18/2022
• Device Catalogue Number: M0035422540
• Device Lot Number: 21445902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2019
• Initial Date Received by Manufacturer: 10/28/2019
• Supplement Date Received by Manufacturer: 12/20/2019
• Initial Report FDA Received Date: 11/04/2019
• Supplement Report FDA Received Date: 01/03/2020
• 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: EXCELSIOR SL-10 MICROCATHETER (STRYKER); SNARE DEVICE (UNKNOWN MANUFACTURER)
• Outcome Attributed to Adverse Event: Required Intervention