MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL ULTRA 2MM X 3CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035432030
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject is not available.
Event or Problem Description
It was reported while advancing the coil (subject device) into the microcatheter there was friction and the coil could not be advanced to the target lesion.When withdrawn from the catheter, the coil was missing.The operator then used a guidewire to advance the microcatheter and retrieve the coil.The coil was replaced and the procedure was completed successfully.There were no clinical consequences to the patient.
Event or Problem Description
It was reported while advancing the coil (subject device) into the microcatheter there was friction and the coil could not be advanced to the target lesion.When withdrawn from the catheter, the coil was missing.The operator then used a guidewire to advance the microcatheter and retrieve the coil.The coil was replaced and the procedure was completed successfully.There were no clinical consequences to the patient.
Additional Manufacturer Narrative
D4- expiration date- updated.H3- device evaluation & summary attached- updated.H4- manufacturing date- updated.The device history record confirms that the device met all material, assembly and performance specifications.Visual inspection was performed on the returned sample and it was observed the main coil was manually detached and the proximal contact wire was intact.The coil delivery wire was kinked/bent and the distal tip was found to be intact.The main coil was stretched and the suture was damaged.Functional could not be performed based on damage to product as the coil was returned detached.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.The reported event was confirmed.The device was returned for analysis and coil was found kinked/bent and stretched with suture damaged.Also, coil was broken/fractured.In the case of this complaint, it is most likely that anatomical or procedural factors resulted to friction during advancement/retraction of the coil and causing the coil to stretch/kinked and then break (together with the suture) during manipulation.The event appears to be associated with a product that met stryker and design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural or anatomical factors during use.Therefore assignable cause of procedural factors will be assigned to reported issue.

• Brand Name: TARGET HELICAL ULTRA 2MM X 3CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• MDR Report Key: 9451436
• Report Number: 3008881809-2019-00387
• Device Sequence Number: 2114905
• Product Code: HCG
• UDI-Device Identifier: 04546540675996
• UDI-Public: 04546540675996
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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): 02/07/2020

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: 05/07/2022
• Device Model Number: M0035432030
• Device Catalogue Number: M0035432030
• Device Lot Number: 21405687
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Initial Date Received by Manufacturer: 11/18/2019
• Supplement Date Received by Manufacturer: 01/17/2020
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 02/07/2020
• 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: ECHELON-10 MICROCATHETER (UNKNOWN); SYNCHRO GUIDEWIRE (STRYKER)
• Patient Age: 42 YR