MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL ULTRA 2.5 MM X 4 CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035432540
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.Analysis of the device revealed that the proximal contact and the delivery wire was kinked likely due to handling.Procedural fluid was noted in the introducer sheath, the main coil was stretched and broken.The main coil suture was damaged (physical break).Functional testing could not be performed due to the condition of the returned device.Information available indicated that no anomalies were noted to the device prior to use and there is no indication of a use error.The anatomy was noted to be tortuous which may have contributed to the reported event.It is probable that the device was damaged during the clinical procedure causing the as reported issue and observed damage.Therefore an assignable cause of operational context has been assigned to this investigation.
Event or Problem Description
Analysis of the returned device found that the coil was broken.There was no clinical consequences to the patient reported due to the event.

• Brand Name: TARGET HELICAL ULTRA 2.5 MM X 4 CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7232915
• Report Number: 3008881809-2018-00054
• Device Sequence Number: 1447925
• Product Code: HCG
• UDI-Device Identifier: 04546540676047
• UDI-Public: (01)04546540676047(17)190331(10)18935114
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K112385
• 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
• Report Date (Section B): 01/31/2018

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: 03/31/2019
• Device Model Number: M0035432540
• Device Catalogue Number: M0035432540
• Device Lot Number: 18935114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2018
• Initial Report FDA Received Date: 01/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR