MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL NANO 1MM X 3CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035431030
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, that the subject coil could not be advanced into proximal of microcatheter.During adjustments, the subject coil detached prematurely inside the microcatheter.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
H3 other text : the device is not available to the manufacturer.
Event or Problem Description
It was reported that the subject coil could not be advanced into proximal of microcatheter, during adjustments the subject coil detached prematurely inside the microcatheter.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
Section b1 adverse event/product problem - corrected - no product problem.Section h1 type of reportable event - corrected - no malfunction.H4 manufacturing date ¿ added.H3 device evaluated by mfg ¿updated.H3 summary attached - updated.D4 expiration date - added.D9 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the main coil was found to be kinked/bent and stretched, the subject coil was found to be attached to the coil delivery wire.No detachment/breakage noted, the coil delivery wire was found to be intact, the coil introducer sheath was found to be intact.During a functional test, friction was encountered inside the coil introducer sheath caused by kinked/band and stretched coil.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.The reported main coil prematurely detached/separated during use was not confirmed during the analysis.The reported coil in catheter friction could not be replicated; however, the analysis results are consistent with the reported event.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.During analysis, the main coil was found to be stretched and kinked/bent.There was no detachment on breakage noted.The coil delivery and coil introducer sheath were found to be intact.An assignable cause of procedural factors will be assigned to the as reported 'coil in catheter friction' and to the as analyzed codes 'main coil kinked/bent', 'main coil stretched' and 'coil introducer sheath friction' as these defects are 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 and/or anatomical factors during use.An assignable code of not confirmed will be assigned to the as reported 'main coil prematurely detached/separated during use' as the defect was not confirmed during the analysis.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.

• Brand Name: TARGET HELICAL NANO 1MM X 3CM
• 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: 16737832
• Report Number: 3008881809-2023-00186
• Device Sequence Number: 6709720
• Product Code: HCG
• UDI-Device Identifier: 04546540698018
• UDI-Public: 04546540698018
• 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,Followup
• Report Date (Section B): 06/22/2023

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: 10/04/2024
• Device Model Number: M0035431030
• Device Catalogue Number: M0035431030
• Device Lot Number: 23202486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2023
• Supplement Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2021
• 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: ATLAS STENT (STRYKER); SL-10 MICROCATHETER (STRYKER); SYNCHRO2 GUIDEWIRE (STRYKER); TARGET COILS (STRYKER); XT17 CATHETER (STRYKER)
• Patient Sex: Unknown
• Patient Race: Asian