MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 STANDARD 15 MM X 40CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035461540
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Analysis of the returned device found that the subject coil was found prematurely deployed during use.There were no clinical consequences to the patient reported as a result of this event and the procedure was completed successfully.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the main coil was seen to be stretched.The main coil was seen to be kinked and the suture was seen to be damaged.The coil delivery wire and introducer sheath were not returned.During functional inspection, the coil was returned with an microcatheter, in order to determine if the coil had been returned inside the catheter, the catheter was cut and the detached coil was removed from the catheter.The coil was broken removing from the catheter during analysis.The reported event is covered in the device directions 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.Additional information provided by the customer was resistance was encountered and the coil could not be advanced or retracted within the microcatheter.It was reported that the device was prepared as per the dfu, that there was no damage noted to the packaging prior to opening and the device was confirmed to be in good condition during preparation/prior to use on the patient and continuous flush was set up and maintained throughout the procedure.During the device analysis, the main coil was returned detached inside an returned microcatheter, the coil was removed from the catheter during functional testing and was found to be stretched, kinked and the coil suture was also found to be damaged.The coil delivery wire and introducer sheath were not returned for analysis.Its likely the coil was damaged due to manipulation of the device when the reported resistance was felt within the microcatheter during the clinical procedure, causing the premature deployment.Therefore the as reported code 'coil in catheter friction' and 'coil difficult to remove/withdraw from catheter', as well as the as analyzed codes 'main coil prematurely detached/separated during use', 'main coil stretched', 'main coil kinked/bent' and 'main coil suture damage' will be assigned procedural factors as this complaint appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.

• Brand Name: TARGET 360 STANDARD 15 MM X 40CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 15156442
• Report Number: 3008881809-2022-00379
• Device Sequence Number: 17445318
• Product Code: HCG
• UDI-Device Identifier: 07613252192534
• UDI-Public: 07613252192534
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 08/03/2022

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: 06/20/2024
• Device Model Number: M0035461540
• Device Catalogue Number: M0035461540
• Device Lot Number: 22979147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2022
• Initial Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EV 3 DETACHABLE COIL (MEDTRONIC).; EXCELSIOR XT-17 MICROCATHETER (STRYKER).; SYNCHRO GUIDEWIRE (STRYKER).; UNKNOWN, OCCLUSION BALLOON CATHETER (UNKNOWN).
• Patient Age: 65 YR
• Patient Sex: Unknown
• Patient Race: Asian