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

Catalog Number	M0035431010
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2023
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 acoma aneurysm tiny aneurysm case.Used non-stryker catheter to deliver coil and inserted the first coil (subject device).After it was detached the operator chose another coil to fill and during adjusting the second coil the tail of the first coil (subject device) was pulled together back into microcatheter and the coils got stuck (subject coil migrated (moved out of position once placed)).The operator pushed and pulled the coil delivery wire but the coil could not move.So he had to withdraw the microcatheter and pulled the coil out of patient's body and used new coil to finish the procedure.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 acoma aneurysm tiny aneurysm case.Used non-stryker catheter to deliver coil and inserted the first coil (subject device).After it was detached the operator chose another coil to fill and during adjusting the second coil the tail of the first coil (subject device) was pulled together back into microcatheter and the coils got stuck (subject coil migrated (moved out of position once placed)).The operator pushed and pulled the coil delivery wire but the coil could not move.So he had to withdraw the microcatheter and pulled the coil out of patient's body and used new coil to finish the procedure.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
This is 1 of 2 reports (1st mdr).H4 manufacturing date ¿ added.H3 device evaluated by mfg ¿updated.H3 summary attached - updated.D4 expiration date - added.D9 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.Due to the automated mes (manufacturing execution system) 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 wavy in numerous locations, the coil delivery wire was kinked just after the proximal contact, the main coil was returned detached.There were no anomalies noted to the coil.The coil introducer sheath was not returned.A functional inspection was unable to perform.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 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.During analysis the coil delivery wire was severely kinked.The coil was detached and there were no anomalies noted to the coil.An assignable cause of procedural factors will be assigned to the as reported 'device interaction with another device', 'main coil migration' and 'main coil jammed' as 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 not confirmed will be assigned to the as reported 'main coil tangled' as the event was not confirmed during the analysis.An assignable cause of 'handling damage' will be assigned to the as analyzed 'coil delivery wire kinked/bent' as the defect appears to be associated with handling of the product or portion of the product during preparation.An assignable cause of procedural factors will be assigned to the as analyzed 'main coil prematurely detached/separated during use' as 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 HELICAL NANO 1MM X 1CM
• 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: 17784900
• Report Number: 3008881809-2023-00471
• Device Sequence Number: 12142231
• Product Code: HCG
• UDI-Device Identifier: 04546540700216
• UDI-Public: 04546540700216
• 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): 10/11/2023

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: 09/04/2025
• Device Catalogue Number: M0035431010
• Device Lot Number: 23873566
• 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: 09/12/2023
• Supplement Date Received by Manufacturer: 10/03/2023
• Initial Report FDA Received Date: 09/20/2023
• Supplement Report FDA Received Date: 10/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2022
• 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: ECHELON-10 CATHETER (NON-STRYKER); TARGET COIL (STRYKER)
• Patient Sex: Unknown