MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET TETRA 3.0MM X 6.0CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	TG5413060
Medical Device Problem Codes	Misassembled (1398); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure when the subject coil was inserted into the aneurysm and the operator attempted to align the markers, the entire subject coil came out of the microcatheter prematurely.The subject coil was retrieved.The misalignment with the marker was so large that the microcatheter was left in place and the procedure was successfully completed with a new coil.There were no misalignment issues between the microcatheter and new coil.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
Section b1 adverse event/product problem - corrected - no product problem section h1 type of reportable event - corrected - no malfunction 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 device was returned without the introducer sheath.The coil delivery wire was found to be kinked/bent in multiple areas.The main coil was found to be stretched.During functional test the distance from the proximal end of the delivery wire radiopaque (ro) marker to the distal end of the detachment zone was measured and was less than 32.8 mm, therefore within specifications.The distance from the proximal end of the delivery wire radiopaque marker to the distal end of the cathode was measured and was greater than 31.39, therefore within specification.There was no indication of the ro marker band misalignment found during the analysis; therefore the reported ro marker band misalignment was not confirmed during the analysis.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 not confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.It was reported that there was misalignment of the ro markers in coil with the ro markers in the microcatheter.Additional information provided by the customer indicated that the main coil came out of the microcatheter early due to misalignment of the markers.There was no friction noted while the coil was advancing the introducer sheath.The device was prepared for use as per the dfu.There was no damage noted to the packaging prior to opening the packaging.The device was confirmed to be in good condition during preparation/ prior to use on the patient.Continuous flush was set up and maintained throughout the clinical procedure.There was no resistance noted when the coil was taken out of dispenser hoop/protective tube.During analysis, the coil delivery wire was noted to be kinked/bent in multiple areas.The main coil was found to be stretched.The device was returned without introducer sheath.The distance from the proximal end of the delivery wire radiopaque marker to the distal end of the detachment zone was measured and was less than 32.8 mm, therefore within specifications.The distance from the proximal end of the delivery wire radiopaque marker to the distal end of the cathode was measured and was greater than 31.39, therefore within specification.There was no indication of the ro marker band misalignment found during the analysis; therefore, the reported ro marker band misalignment was not confirmed during the analysis, hence an assignable cause of not confirmed will be assigned to nv - ro marker band misaligned.An assignable cause of procedural factors will be assigned to as analyzed event: ¿main coil stretched¿ 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.An assignable cause of handling damage will be assigned to as analyzed event: ¿coil delivery wire kinked/bent¿ as this complaint appears to be associated with handling of the product or portion of the product during the procedure.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
Event or Problem Description
It was reported that during the procedure when the subject coil was inserted into the aneurysm and the operator attempted to align the markers, the entire subject coil came out of the microcatheter prematurely.The subject coil was retrieved.The misalignment with the marker was so large that the microcatheter was left in place and the procedure was successfully completed with a new coil.There were no misalignment issues between the microcatheter and new coil.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET TETRA 3.0MM X 6.0CM
• 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: 21284650
• Report Number: 3008881809-2025-00062
• Device Sequence Number: 9340349
• Product Code: HCG
• UDI-Device Identifier: 07613327578652
• UDI-Public: (01)07613327578652(17)270210(10)24775227
• 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): 04/04/2025

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 Catalogue Number: TG5413060
• Device Lot Number: 24775227
• 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: 01/09/2025
• Supplement Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 01/31/2025
• Supplement Report FDA Received Date: 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2024
• 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: SL-10 MICROCATHETER (STRYKER).
• Patient Sex: Unknown