MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 3MM X 10CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035423100
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned and the reported lot number was confirmed from the packaging label during visual inspection, the proximal contact was seen to be kinked/bent at the junction and detached during analysis.The coil delivery wire was seen to be kinked/bent and the main coil was seen to be stretched.The coil delivery wire was seen to be broken/fractured approximately 11.5cm from the proximal end of the wire.During the functional inspection, a demo sl-10 catheter used for the functional test.The device was flushed and the coil advanced through the catheter without difficulty.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.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.Additional information provided by the customer indicated that there was no damage noted to the packaging prior to opening the packaging, the device was prepared as per the directions for use and continuous flush was set up and maintained throughout the procedure.The device was used in conjunction with an excelsior sl-10 microcatheter and the patients anatomy was described as 'moderately tortuous'.Resistance was noted when the coil was inside the microcatheter.The delivery wire proximal contact was kinked and the delivery wire itself was kinked in one location and broken in a second location.The main coil was stretched at the coil / delivery wire junction.This complaint appears to be associated with a product that met stryker design and manufacturing specifications but performance was limited due to procedural factors and/or anatomical factors during use.Therefore, an assignable cause of not confirmed will be assigned to the reported event of main coil kinked/bent and an assignable cause of procedural factors will be assigned to both the reported and analyzed code of main coil friction and to the analyzed event of main coil stretched.An assignable cause of handling damage will be assigned to the analyzed event of coil delivery wire broken/fractured during use, coil delivery wire kinked/bent, and coil proximal contact kinked/bent' as it is most likely that this damage occurred due to handling of the device during use.
Event or Problem Description
The device was returned for analysis and the investigation of the device revealed that the coil (subject device) delivery wire was broken during use in the patient.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET 360 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
• MDR Report Key: 12528495
• Report Number: 3008881809-2021-00393
• Device Sequence Number: 4460191
• Product Code: HCG
• UDI-Device Identifier: 04546540675903
• UDI-Public: 04546540675903
• 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
• Report Date (Section B): 09/24/2021

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: 11/18/2023
• Device Model Number: M0035423100
• Device Catalogue Number: M0035423100
• Device Lot Number: 22585545
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/31/2021
• Initial Report FDA Received Date: 09/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR