MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 6MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035476300
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2022
Type of Reportable Event	Malfunction
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 found to be kinked/bent.The main coil was found to be stretched and broken/fractured and the suture was found to damaged.A functional test for the reported event ¿coil in catheter friction¿ was unable to perform 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 could not be confirmed; 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.The device was analyzed.The main coil was found to be stretched and broken/fractured.The main coil suture was found to be damaged.This complaint 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.Therefore, an assignable cause of procedural factors will be assigned to the as reported ¿coil in catheter friction¿ and ¿main coil stretched¿ and to the as analyzed ¿main coil stretched¿, ¿main coil broken/fractured during use¿ and ¿main coil suture damage¿.An assignable cause of handling damage will be assigned to as analyzed ¿coil delivery wire kinked/bent¿ as these defects appear to be associated with handling of the product or portion of the product during the procedure.
Event or Problem Description
It was reported that during the procedure the subject device (coil) could not be advanced out of the microcatheter and was stretched upon withdrawal from the microcatheter.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.The subject device was returned for analysis and it was discovered that the main coil(subject device) was found to be broken/fracture during use.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET 360 SOFT 6MM X 30CM
• 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: 15259314
• Report Number: 3008881809-2022-00401
• Device Sequence Number: 6720570
• Product Code: HCG
• UDI-Device Identifier: 04546540676559
• UDI-Public: 04546540676559
• 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): 08/19/2022

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: 09/21/2024
• Device Model Number: M0035476300
• Device Catalogue Number: M0035476300
• Device Lot Number: 23175111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2022
• Initial Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2021
• 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: SL-10 MICROCATHETER(STRYKER).
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Race: Asian