MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 2MM X 4CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035422040
Medical Device Problem Code	No Visual Prompts/Feedback (4021)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : the device is not available to the manufacturer.
Event or Problem Description
It was reported that during a embolization procedure in the gastric artery, under radioscopic view in patient's body, the subject coil was missed.When observed out of the patient's body, the absence of the subject coil was confirmed.On follow up the customer is unknown if the coil was attached to the delivery wire during preparation/prior to use on the patient.The customer thinks that the subject coil did not exit in the package before insertion that is, not attached in the production process.And therefore, could not find the subject coil anywhere.The customer confirmed that, the subject coil was confirmed to be in good condition during preparation/prior to use on the patient.The subject coil was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that during a embolization procedure in the gastric artery, under radioscopic view in patient's body, the subject coil was missed.When observed out of the patient's body, the absence of the subject coil was confirmed.On follow up the customer is unknown if the coil was attached to the delivery wire during preparation/prior to use on the patient.The customer thinks that the subject coil did not exit in the package before insertion that is, not attached in the production process.And therefore, could not find the subject coil anywhere.The customer confirmed that, the subject coil was confirmed to be in good condition during preparation/prior to use on the patient.The subject coil was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.D4 expiration date - added.Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, functional testing as well as visual 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.A review of manufacturing records indicates that the correct number of component units were issued to the lot.There was no rework, non conformances or note to files associated with this lot which could have contributed to the reported event.All quantity verifications were completed successfully prior to release.Additional information received indicates the tamper seal was intact when the product was received by the customer.As the product packaging was not returned for analysis a packaging inspection could not be completed.As the product/product packaging was not returned and review and analysis of all available information fails to indicate an assignable cause or probable assignable cause.An assignable cause of undeterminable was assigned to the reported missing/incorrect device/component and device or device component not visible under fluoroscopy.

• Brand Name: TARGET 360 ULTRA 2MM X 4CM
• 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: 18799245
• Report Number: 3008881809-2024-00076
• Device Sequence Number: 15236604
• Product Code: HCG
• UDI-Device Identifier: 04546540675842
• UDI-Public: 04546540675842
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K153658
• 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): 04/12/2024

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: 06/11/2026
• Device Catalogue Number: M0035422040
• Device Lot Number: 24377122
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2024
• Supplement Date Received by Manufacturer: 03/29/2024
• Initial Report FDA Received Date: 02/28/2024
• Supplement Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2023
• 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: CARRY LEON CATHETER(UTM K.K., JAPAN)
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian