MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 1MM X 3CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035421030
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during aneurysm embolization procedure, the physician delivered the subject coil using a microcatheter to the target lesion.He tried to advance another coil using the same microcatheter, however the coil could not be advanced out of microcatheter.After checking, he found that the subject coil was detached within the microcatheter and was stuck at the tip of the microcatheter.He tried to push it using a guidewire however, the subject coil could not be pushed out.The physician then removed the subject coil along with the microcatheter.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.During visual/microscopic inspection, the main coil was seen to be kinked/bent and stretched.The main coil was seen to be detached.The coil delivery wire was not returned.The introducer sheath was not returned.Functional inspection could not be carried out due to the 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 complaint was confirmed based on 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 was the device was prepared as per the dfu and that continuous flush was set up and maintained throughout the clinical procedure.During analysis, the main coil was returned in the condition of being detached and was also found to be kinked and stretched, confirming the reported event.The coil delivery wire and introducer sheath were not returned for device analysis.The as reported ¿main coil prematurely detached/separated during use¿ and ¿coil jammed¿ as well as the as analyzed ¿main coil kinked/bent¿, ¿main coil stretched¿ and ¿main coil prematurely detached/separated during use¿ will be assigned procedural factors as 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.
Event or Problem Description
It was reported that during aneurysm embolization procedure, the physician delivered the subject coil using a microcatheter to the target lesion.He tried to advance another coil using the same microcatheter, however the coil could not be advanced out of microcatheter.After checking, he found that the subject coil was detached within the microcatheter and was stuck at the tip of the microcatheter.He tried to push it using a guidewire however, the subject coil could not be pushed out.The physician then removed the subject coil along with the microcatheter.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET 360 NANO 1MM X 3CM
• 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: 15868636
• Report Number: 3008881809-2022-00592
• Device Sequence Number: 6699794
• Product Code: HCG
• UDI-Device Identifier: 04546540697974
• UDI-Public: 04546540697974
• 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): 12/23/2022

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: 01/22/2025
• Device Model Number: M0035421030
• Device Catalogue Number: M0035421030
• Device Lot Number: 23430632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/01/2022
• Supplement Date Received by Manufacturer: 12/09/2022
• Initial Report FDA Received Date: 11/28/2022
• Supplement Report FDA Received Date: 12/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2022
• 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 XT 27 MICROCATHETER (STRYKER); SYNCHRO 2 GUIDEWIRE (STRYKER); TARGET COIL (STRYKER)
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Weight: 75 KG