MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 3MM X 10CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035423100
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Analysis of the returned device found that the coil (subject device) was broken/fractured during use.There were no clinical consequences to the patient reported as a result of this event and the procedure was completed successfully.
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.During visual/microscopic inspection, the main coil was seen to be stretched.The main suture was seen to be damaged, and the main coil was also seen to be broken.Functional inspection was not applicable.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 coil in catheter friction could not be duplicated; however, the analysis results are consistent with the reported event.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, coil to go into microcatheter and before it reached tip of microcatheter big resistance was encountered and it could not be advanced any more.The patient¿s anatomy was not tortuous.The device was prepared as per dfu.The device was seen to be in good condition prior to use on the patient.During analysis, the main coil was seen to be broken, stretched and the suture damaged.Functional testing could not be carried out.An assignable cause of ¿procedural factors¿ will be assigned to the as reported ¿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 as analyzed ¿main coil stretched¿ and ¿main coil broken/fractured during use¿ and ¿main coil suture damaged¿ 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.

• Brand Name: TARGET 360 ULTRA 3MM X 10CM
• 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: 19140087
• Report Number: 3008881809-2024-00173
• Device Sequence Number: 9437966
• Product Code: HCG
• UDI-Device Identifier: 04546540675903
• UDI-Public: 04546540675903
• 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
• Report Date (Section B): 04/18/2024

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: 05/29/2025
• Device Catalogue Number: M0035423100
• Device Lot Number: 23685314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2024
• Initial Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2022
• 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: ENVOY GUIDE CATHETER (JOHNSON & JOHNSON); EXCELSIOR SL-10 MICROCATHETER (STRYKER); NEUROFORM ATLAS STENT (STRYKER); SYNCHRO GUIDEWIRE (STRYKER); TARGET COIL (STRYKER)
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Race: Asian