MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET TETRA 2.0MM X 4.5CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	TG5412045
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the subject coil felt a little rough during transfer, continued to advance the subject coil and the physician felt that the subject coil did not track as well as normal.Subject coil successfully deposited without detachment.Upon detachment, the pusher wire was retracted.As the microcatheter was retracted out of the anx, it was noted that the subject coil was still captured within the microcatheter.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
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 was returned within the catheter, the main coil was seen to be detached, the main coil was seen to be stretched and kinked.A functional test was unable to perform as only main coil 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 main coil difficulty inserting could not be confirmed/replicated however, the analysis results are consistent with the reported event.The reported main coil prematurely detached/separated during use was confirmed during analysis.There was no damages noted to the device prior to use and continues flush was maintained during the procedure.There was no damages noted to the device prior to use and continues flush was maintained during the procedure.The device was analyzed and the coil delivery wire was not returned but the proximal end of the coil was stuck in the distal end of the sl-10.The main coil was analyzed and it was seen to be stretched and kinked/bent.It was noted the main coil was prematurely detached/separated during use.An assignable cause of procedural factors will be assigned to the as reported 'main coil difficulty inserting¿, ¿main coil prematurely detached/separated during use¿, and to the as analyzed ¿main coil stretched¿, ¿main coil kinked/bent¿, and ¿main coil prematurely detached/separated during use¿ as these 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.
Event or Problem Description
It was reported that the subject coil felt a little rough during transfer, continued to advance the subject coil and the physician felt that the subject coil did not track as well as normal.Subject coil successfully deposited without detachment.Upon detachment, the pusher wire was retracted.As the microcatheter was retracted out of the anx, it was noted that the subject coil was still captured within the microcatheter.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

• Brand Name: TARGET TETRA 2.0MM X 4.5CM
• 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: 16738920
• Report Number: 3008881809-2023-00188
• Device Sequence Number: 6597333
• Product Code: HCG
• UDI-Device Identifier: 07613327578591
• UDI-Public: 07613327578591
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 05/19/2023

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: 11/26/2025
• Device Model Number: TG5412045
• Device Catalogue Number: TG5412045
• Device Lot Number: 24048810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2023
• Supplement Date Received by Manufacturer: 05/05/2023
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 05/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2022
• 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: DAC CATHETER (STRYKER).; INFINITY LONG SHEATH (STRYKER).; SL-10 MICROCATHETER (STRYKER).
• Patient Sex: Unknown