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

Model Number	M0035433100
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device is unavailable to manufacturer.
Event or Problem Description
It was reported that during procedure, when the subject coil was advancing in the microcatheter, the subject coil was observed under the fluoroscopy to be broken (at distal part).The medical intervention was performed to remove the broken part and introduce with another coil resulting 30 minutes surgical delay.The procedure was completed with a new coil.No further information is available.
Event or Problem Description
It was reported that during procedure, when the subject coil was advancing in the microcatheter, the subject coil was observed under the fluoroscopy to be broken (at distal part).The medical intervention was performed to remove the broken part and introduce with another coil resulting 30 minutes surgical delay.The procedure was completed with a new coil.No further information is available.
Additional Manufacturer Narrative
Section b1 product problem: corrected: no product problem as the subject main coil was not broken.Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.Visual inspection revealed that subject coil delivery wire was seen to be kinked.The main coil was seen to be stretched but it still attached and have no breaks present.Functional inspection was performed as the subject coil device was flushed but could not be advanced in the introducer sheath.The device had to be retracted out of the sheath.The reported event ¿main coil broken/fractured during use¿ was not confirmed during analysis as the coil was not broken.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.An assignable cause of ¿anticipated procedural complication¿ will be assigned to the reported ¿patient medical or surgical intervention required¿, as a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted with the directions for use, product labeling and/or risk documentation files.The coil delivery wire was found to be kinked/ bent; and the main coil was found to be stretched.An assignable cause of ¿procedural factors¿ will be assigned to the as analyzed ¿main coil stretched' and ¿coil introducer sheath friction' as these defects are 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.An assignable cause of ¿handling damage¿ will be assigned to the as analyzed ¿coil delivery wire kinked/bent' since it is most likely that this damage occurred due to handling of delivery wire during the clinical procedure.An assignable cause of 'not confirmed' was assigned to the reported event ¿main coil broken/fractured during use' as the issue included a returned product review (visual, physical, and/or performance testing) which showed no evidence of either the alleged issue(s) or any defect which could have contributed to the event.

• Brand Name: TARGET HELICAL 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: 12374654
• Report Number: 3008881809-2021-00347
• Device Sequence Number: 4418433
• Product Code: HCG
• UDI-Device Identifier: 04546540676092
• UDI-Public: 04546540676092
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/14/2024
• Device Model Number: M0035433100
• Device Catalogue Number: M0035433100
• Device Lot Number: 22732409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/05/2021
• Supplement Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 08/26/2021
• Supplement Report FDA Received Date: 02/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2021
• 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: MICROCATHETER (UNKNOWN MANUFACTURER); MICROCATHETER (UNKNOWN MANUFACTURER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female