MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 7MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035477200
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : the device is not available to the manufacurer.
Event or Problem Description
It was reported that during left posterior communicating artery (pcoma) aneurysm procedure, the operator prepared to fill the subject coil.However, when advancing the subject coil inside the microcatheter big resistance was encountered.The operator withdrew the subject coil and found it fractured.The subject device was replaced, and 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) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection the coil delivery wire was noted to be kinked.The main coil was seen to be broken from the delivery wire.The main coil was seen to be severely stretched and the main coil suture was damaged.The coil introducer sheath was intact.Functional inspection to test the reported defect ¿main coil broken/fractured during use¿ was not required.Functional inspection to test the reported defect ¿coil in catheter friction¿ could not be performed due to condition of the device.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 event was confirmed based on the device analysis.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 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.The patient¿s anatomy was moderately tortuous.During analysis, the coil delivery wire was noted to be kinked, the main coil was broken, stretched and the suture was damaged.An assignable cause of procedural factors will be assigned to the reported defect 'main coil broken/fractured during use¿ and ¿coil in catheter friction¿ 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 procedural factors will be assigned to the analysed defects ¿main coil broken/fractured during use¿, ¿main coil stretched¿ and ¿main coil suture damage¿ 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.An assignable cause of 'handling damage' will be assigned to the analysed defect ¿coil delivery wire kinked/bent¿ as the defect appears to be associated with handling of the product or portion of the product during preparation.
Event or Problem Description
It was reported that during left posterior communicating artery (pcoma) aneurysm procedure, the operator prepared to fill the subject coil.However, when advancing the subject coil inside the microcatheter big resistance was encountered.The operator withdrew the subject coil and found it fractured.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET 360 SOFT 7MM X 20CM
• 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: 17712021
• Report Number: 3008881809-2023-00460
• Device Sequence Number: 20520410
• Product Code: HCG
• UDI-Device Identifier: 04546540676573
• UDI-Public: 04546540676573
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 11/03/2023

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: 02/01/2025
• Device Catalogue Number: M0035477200
• Device Lot Number: 23448928
• 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: 08/14/2023
• Supplement Date Received by Manufacturer: 10/11/2023
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 11/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2022
• 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: EXCELSIOR SL-10 MICROCATHETER (STRYKER)
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 63 KG
• Patient Race: Asian