MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET TETRA 3.5MM X 6.0CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	TG5413560
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	05/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 other text : the device is implanted in the patient.
Event or Problem Description
It was reported that during an endovascular coil embolization procedure of acom aneurysm in a patient, the power supply failed to detach the subject coil and during this time the physician pushed the subject coil a little too far and it slightly perforated the aneurysm.It was a tiny perforation.The physicain ended up putting a few extra coils in and also used a balloon to control bleeding at the time.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, visual testing as well as functional testing cannot be 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 complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.Based upon medical review, the harm observed in this complaint is anticipated in nature as per the device risk assessment.As a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted within the dfu, product labeling and/or risk documentation files, an assignable cause of anticipated procedural complication will be assigned to this complaint.
Event or Problem Description
It was reported that during an endovascular coil embolization procedure of acom aneurysm in a patient, the power supply failed to detach the subject coil and during this time the physician pushed the subject coil a little too far and it slightly perforated the aneurysm.It was a tiny perforation.The physicain ended up putting a few extra coils in and also used a balloon to control bleeding at the time.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET TETRA 3.5MM 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: 17188387
• Report Number: 3008881809-2023-00315
• Device Sequence Number: 20300876
• Product Code: HCG
• UDI-Device Identifier: 07613327578683
• UDI-Public: 07613327578683
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 08/21/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/26/2025
• Device Model Number: TG5413560
• Device Catalogue Number: TG5413560
• Device Lot Number: 24048817
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2023
• Supplement Date Received by Manufacturer: 08/17/2023
• Initial Report FDA Received Date: 06/23/2023
• Supplement Report FDA Received Date: 08/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: ECHELON 10 MICRO CATHETER (NON STRYKER); SCEPTOR BALLOON (NON STRYKER); SYNCHRO GUIDEWIRE (STRYKER
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 48 YR
• Patient Sex: Male