MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL ULTRA 3MM X 10CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035433100
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure of cerebral aneurysm treatment the subject coil delivery wire fractured in the microcatheter.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Event or Problem Description
It was reported that during the procedure of cerebral aneurysm treatment the subject coil delivery wire fractured in the microcatheter.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
The returned product was confirmed to be the product reported in the complaint.During visual inspection, the subject mail coil was found not returned and broken off the delivery wire.The coil delivery wire was noted kinked/bent and coil introducer sheath was found intact.Functional inspection was not performed as the results from visual inspection were sufficient.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.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 device was returned for analysis and the reported event was not confirmed.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 broken off the coil delivery wire and not returned.The coil delivery wire was found to be kinked/bent.An assignable cause of not confirmed will e assigned to the as reported event of coil delivery wire broken/fractured during use as the defect was not confirmed during the analysis.An assignable cause of procedural factors will be assigned to the as analyzed event of main coil broken/fractured during use as the defect 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.An assignable cause of handling damage will be assigned to the as analyzed event of coil delivery wire kinked/bent as the defect appears to be associated with handling of the product or portion of the product during the procedure.

• Brand Name: TARGET HELICAL ULTRA 3MM X 10CM
• 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: 15265229
• Report Number: 3008881809-2022-00406
• Device Sequence Number: 20477214
• Product Code: HCG
• UDI-Device Identifier: 04546540676092
• UDI-Public: 04546540676092
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• 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): 11/02/2022

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: 02/13/2025
• Device Model Number: M0035433100
• Device Catalogue Number: M0035433100
• Device Lot Number: 23470231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2022
• Supplement Date Received by Manufacturer: 10/12/2022
• Initial Report FDA Received Date: 08/22/2022
• Supplement Report FDA Received Date: 11/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2022
• 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: EXCELSIOR SL-10 MICROCATHETER (STRYKER); EXCELSIOR SL-10 MICROCATHETER (STRYKER)
• Patient Age: 40 YR
• Patient Sex: Female