MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 4MM X 8CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035474080
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2022
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 proximal contact and the coil delivery wire was found to be kinked/bent.The coil and coil delivery wire was seen to be broken/fractured.The main coil was seen to be tangled.The main coil was seen to be stretched.Functional inspection cannot be performed due to the condition of the returned 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.Additional information provided by the customer indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient, the device was prepared as per the dfu.Also, additional information indicated that continuous flush was set up and maintained throughout the clinical procedure.During the analysis, the proximal contact was seen to be kinked, the coil delivery wire was seen to be kinked/bent, the coil was seen to be broken/fractured, the coil delivery wire was seen to be broken, the main coil was seen to be tangled, the main coil was seen to be stretched.Therefore the as reported code 'coil in catheter friction', as well the as analyzed codes, 'coil delivery wire broken/fractured during use', 'main coil broken/fractured during use', 'main coil tangled' and 'main coil stretched' 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.The as analyzed codes, 'coil proximal contact kinked/bent' and 'coil delivery wire kinked bent' will be assigned handling damage as the issue is due to handling of the product or portion of the product during the clinical procedure, upon removal of the product from the packaging, or preparation of the product prior to use.
Event or Problem Description
Analysis of the returned device found the main coil and coil delivery wire was found broken/fractured during use.There were no clinical consequences to the patient reported as a result of this event.

• Brand Name: TARGET 360 SOFT 4MM X 8CM
• 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: 14548667
• Report Number: 3008881809-2022-00254
• Device Sequence Number: 6774703
• Product Code: HCG
• UDI-Device Identifier: 04546540676467
• UDI-Public: 04546540676467
• 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): 05/31/2022

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: 06/06/2024
• Device Model Number: M0035474080
• Device Catalogue Number: M0035474080
• Device Lot Number: 22948861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2022
• Initial Report FDA Received Date: 05/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2021
• 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: EXCELSIOR SL-10 MICROCATHETER (STRYKER)
• Patient Sex: Unknown
• Patient Race: Asian