MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 10MM X 40CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036121040
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an anterior communicating artery unruptured aneurysm coil embolization procedure, physician deployed a stent and then inserted the subject coil into the microcatheter, however resistance was encountered at the middle of the catheter shaft.Physician tried to retrieve the subject coil however, the subject coil broke off.Thus, the entire microcatheter was removed.The subject coil was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
D9 / h3 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.H3 device evaluated by mfg ¿updated.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 and microscopic inspection, the subject coil was returned with microcatheter.The subject coil delivery wire was seen to be kinked/bent in multiple areas and the main coil was seen to be severely stretched.The subject main coil suture was seen to be damaged and main coil was found to be broken/fractured in multiple areas.Functional testing revealed only partial subject main coil was returned outside of the microcatheter.Potency mandrel 0.058' was advanced through the microcatheter and the remaining subject mail coil was retrieved.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 main coil broken/fractured event was confirmed during the analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.The information provided in the complaint indicates that resistance was encountered during advancement of the subject coil within the microcatheter.It is likely that this resistance resulted in the coil damage/fractures.A probable cause of procedural factors will be assigned to the as reported codes coil in catheter friction, main coil broken/fractured during use, and to as analyzed codes main coil stretched, main coil suture damage, main coil broken/fractured during use since these issues appear 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 and/or anatomical factors during use.It is likely that the subject coil delivery wire was kinked during the procedure as excessive force may have been applied when the subject coil was advanced/retracted with friction noted.Because this defect appears to be associated with handling of the product or portion of the product during the procedure, a probable cause of handling damage will be assigned to the as analyzed code coil delivery wire kinked/bent.
Event or Problem Description
It was reported that during an anterior communicating artery unruptured aneurysm coil embolization procedure, physician deployed a stent and then inserted the subject coil into the microcatheter, however resistance was encountered at the middle of the catheter shaft.Physician tried to retrieve the subject coil however, the subject coil broke off.Thus, the entire microcatheter was removed.The subject coil was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET XL 360 SOFT 10MM X 40CM
• 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: 19644981
• Report Number: 3008881809-2024-00287
• Device Sequence Number: 7526616
• Product Code: HCG
• UDI-Device Identifier: 07613327004601
• UDI-Public: 07613327004601
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 09/16/2024

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: 09/24/2026
• Device Catalogue Number: M0036121040
• Device Lot Number: 24545709
• 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: 06/06/2024
• Supplement Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 09/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2023
• 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: HEADWAY 17 MICROCATHETER (MICROVENTION).
• Patient Sex: Unknown