MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET TETRA 3.0MM X 8.0CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	TG5413080
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The device was returned for analysis and the investigation of the device revealed that the subject coil delivery wire had broken during use.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.The device was returned for analysis, and it was noted that the returned microcatheter was noted to be blocked at the hub with dried procedural fluid.The subject coil delivery wire was returned inside the introducer sheath.The delivery wire was kinked.The main coil was not returned and it was determined that the pi wire had broken at the proximal side of the detachment zone.A significant presence if blood was noted on the device.The functional inspection was not performed since the main coil was not returned.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 complaint was confirmed based on analysis of the returned device.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information provided by the customer indicated that there was no damage noted to the packaging prior to opening the packaging.The coil was stuck in the introducer sheath.The reported event: coil introducer sheath friction could not be confirmed during analysis since the main coil was not returned and will be assigned a probable cause of undeterminable.The as analysed codes coil delivery wire kinked/bent and coil delivery wire broken/fractured during use will be assigned a probable cause of handling damage because this complaint appears to be associated with handling of the product or portion of the product during the procedure.

• Brand Name: TARGET TETRA 3.0MM X 8.0CM
• 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: 20292862
• Report Number: 3008881809-2024-00436
• Device Sequence Number: 7284747
• Product Code: HCG
• UDI-Device Identifier: 07613327578669
• UDI-Public: 07613327578669
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K222533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/24/2024

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: 10/03/2026
• Device Catalogue Number: TG5413080
• Device Lot Number: 24559620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2023
• 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