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

Model Number	M0035431030
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coil would not track and broke.The physician retracted the coil and used another coil to complete the procedure.There were no reported clinical consequences to the patient.
Additional Manufacturer Narrative
Event or Problem Description
It was reported that the coil would not track and broke.The physician retracted the coil and used another coil to complete the procedure.There were no reported clinical consequences to the patient.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The subject device was returned within the introducer sheath and dispenser hoop.Visual inspection of the device revealed that the delivery wire and main coil were kinked.The main coil was stretched as well.The reported coil break could not be confirmed during analysis.During functional testing the coil could only be retracted in the introducer sheath.The device was confirmed to be in good condition prior to use.Therefore, an assignable cause of "not confirmed" has been assigned to the reported event.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.This is a correction follow up mdr.Previously submitted follow-up report under mfr # 3008881809-2016-00318 is being re-submitted under mfr# mdr 3008881809-2016-00247 per request from fda medwatch program.
Event or Problem Description
It was reported that the coil would not track and broke.The physician retracted the coil and used another coil to complete the procedure.There were no reported clinical consequences to the patient.

• Brand Name: TARGET HELICAL 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
• MDR Report Key: 6080345
• Report Number: 3008881809-2016-00247
• Device Sequence Number: 1123829
• Product Code: HCG
• UDI-Device Identifier: 04546540698018
• UDI-Public: (01)04546540698018(17)190731(10)19186152
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K093142
• 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,Followup
• Report Date (Section B): 11/04/2020

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: 07/31/2019
• Device Model Number: M0035431030
• Device Catalogue Number: M0035431030
• Device Lot Number: 19186152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2016
• Initial Date Received by Manufacturer: 10/10/2016
• Supplement Date Received by Manufacturer: Not provided; 10/09/2020
• Initial Report FDA Received Date: 11/04/2016
• Supplement Report FDA Received Date: 11/07/2016; 11/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HEADWAY MICROCATHETER (MICROVENTION); HEADWAY MICROCATHETER (MICROVENTION)