MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 1.5MM X 4CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035421540
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 coil delivery wire was noted to be kinked/bent, the coil delivery wire was noted to be broken/fractured, and the main coil was noted to be kinked/bent and stretched.A functional inspection could not be performed due to coil delivery wire broken/fractured.The reported complaint was confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.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.During analysis the main coil was found to be stretched and kinked, in the case of this complaint it is most likely that the coil got damaged during coil advancement against friction.So therefore, the as reported ¿coil in catheter friction¿ as well as the as analyzed ¿main coil stretched¿ and ¿main coil kinked/bent¿ will be assigned procedural factors as this event/defects 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.Based on the analysis, the coil delivery wire was seen to be kinked bent and broken/fractured, it can be presumed that when friction was felt in the procedure, the device was mishandled, or force was placed on the delivery wire which caused it to kink and break.Therefore, the as analyzed ¿coil delivery wire kinked bent¿ and ¿coil delivery wire broken/fractured during use¿ will be assigned handling damage as this complaint appears to be associated with handling of the product or portion of the product during the procedure, a probable cause of handling damage was assigned.
Event or Problem Description
Analysis of the returned device found the coil delivery wire (subject device) broken/fractured.There were no clinical consequences to the patient reported as a result of this event.

• Brand Name: TARGET 360 NANO 1.5MM X 4CM
• 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: 12921886
• Report Number: 3008881809-2021-00507
• Device Sequence Number: 5143077
• Product Code: HCG
• UDI-Device Identifier: 04546540697998
• UDI-Public: 04546540697998
• 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): 12/02/2021

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: 09/20/2023
• Device Model Number: M0035421540
• Device Catalogue Number: M0035421540
• Device Lot Number: 22453465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2021
• Initial Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2020
• 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: 6F GUIDE CATHETER(STRYKER); AXIUM (NON-STRYKER); ECHELON (NON-STRYKER); EP2 (NON-STRYKER); SLIME GUIDEWIRE; SYNCHRO (STRYKER); TARGET (STRYKER); TRANSEND (STRYKER)
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Race: Asian