MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL ULTRA 4MM X 8CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035434080
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned and the lot number was confirmed with the packaging returned with the device.During visual inspection, the coil delivery wire was seen to be kinked/bent and the coil broken/fractured.The device was returned without a sheath.Functional testing was unable to be performed as coil was returned broken/fractured.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 no damage was noted to the packaging prior to opening the packaging and the device was confirmed to be in good condition during preparation/prior to use on the patient.The device was prepared for use as per the directions for use.Continuous flush was set up and maintained throughout the clinical procedure.The patients anatomy was described as 'not tortuous'.The subject coil under investigation (target helical 4mm x 8cm) experienced 'big resistance' before it reached the tip of the non-stryker microcatheter and could not be advanced despite several attempts.It was then retracted and replaced with a new coil.There is no mention that a new microcatheter was used for the replacement coil so it is assumed that the additional damage to the coil (breakage/fracture) occurred after the coil was successfully retracted from the microcatheter.The reported event of the coil in catheter friction as well as the analyzed event of main coil broken/fractured during use can be assigned procedural factors as this complaint appears 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 factors.An assignable cause of handling damage will be assigned to the reported event of coil delivery wire kinked/bent since this issue is likely due to handling of the device during the clinical procedure.
Event or Problem Description
The device was returned for analysis and the investigation of the device revealed that the coil (subject device) was broken/fractured during use.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET HELICAL ULTRA 4MM X 8CM
• 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: 12425038
• Report Number: 3008881809-2021-00358
• Device Sequence Number: 19727982
• Product Code: HCG
• UDI-Device Identifier: 04546540676115
• UDI-Public: 04546540676115
• 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): 09/03/2021

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: 02/23/2023
• Device Model Number: M0035434080
• Device Catalogue Number: M0035434080
• Device Lot Number: 22162164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 09/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Weight: 68