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	Foreign Body In Patient (2687)
Date of Event	04/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after the subject coil was detached and the delivery wire was removed, the operator noticed that the small part of the subject coil remained in the detachment junction area.The operator removed the small part of the subject coil.The procedure was completed successfully, no further information available.
Additional Manufacturer Narrative
H3 other text: the device is not available to the manufacturer.
Additional Manufacturer Narrative
H3 device evaluated by mfg ¿updated.D9 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection the delivery wire was seen to be kinked/bent in multiple areas.The main coil was seen to be detached/separated from the delivery wire.The main coil was seen to be kinked/bent.Functional inspection was not performed.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 events were not confirmed during analysis, the main coil was found to be detached prematurely during use.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 is, it was found that a small part of the coil remained in the detachment junction area when the delivery wire was removed after detachment (short beep was confirmed).Only the wire with the small coil part was removed and the procedure completed.The patient¿s anatomy was normal.The device was prepared as per dfu.The device was seen to be in good condition prior to use on the patient and continues flush was set up and maintained throughout the procedure.During analysis, the main coil was seen to be detached and kinked, the delivery wire was kinked in numerous areas.The reported event was not confirmed as main coil length were within specification with no breaks or fractures noted.An assignable cause of ¿not confirmed¿ will be assigned to the reported events ¿un-retrieved device fragments¿ and ¿main coil broken/fractured during use¿ as the vents were not confirmed during analysis.An assignable cause of procedural factors will be assigned to the analyzed events 'main coil prematurely detached/separated during use¿ and ¿main coil kinked/bent¿ 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 analyzed event ¿coil delivery wire kinked/bent¿ as the event appears to be associated with handling of the product or portion of the product.
Event or Problem Description
It was reported that after the subject coil was detached and the delivery wire was removed, the operator noticed that the small part of the subject coil remained in the detachment junction area.The operator removed the small part of the subject coil.The procedure was completed successfully, no further information available.

• 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: 19294400
• Report Number: 3008881809-2024-00212
• Device Sequence Number: 8687568
• Product Code: HCG
• UDI-Device Identifier: 07613327578669
• UDI-Public: 07613327578669
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K222533
• 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): 07/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/07/2026
• Device Catalogue Number: TG5413080
• Device Lot Number: 24474494
• 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: 04/26/2024
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 05/10/2024
• Supplement Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2023
• 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: POWER SUPPLY (UNKNOWN).
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown