MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 2MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number M0035422060

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/29/2019

Event Type  malfunction  

Manufacturer Narrative

The electronic device history record (edhr) review confirms that the device met all material, assembly and performance specifications.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.During analysis, the coil was found to be broken/fractured.The damage noted to the main coil is indicative of the as reported defect.It is likely that the main coil was damaged during use which led to friction in the introducer sheath and catheter as reported initially.Based on the investigation, these defects appear 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 or anatomical factors during use.Therefore, a probable cause of procedural factors was assigned to the as reported event coil in catheter friction and the as analyzed events coil broken/fractured and coil introducer sheath friction.It can be presumed that the delivery wire was damaged during the procedure as force may have been applied when the friction was felt.Because this defect appears to be associated with handling of the product or portion of the product during the procedure/upon removal of the product from the packaging/preparation of the product prior to use, a probable cause of handling damage was assigned to the as analyzed events coil delivery wire kinked bent and coil proximal contact wire broken/fractured.

Event Description

Analysis of the returned device found that the main coil broken/fractured during use.There was no clinical consequences to the patient as a result of this event.

• Brand Name: TARGET 360 ULTRA 2MM X 6CM
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 9593296
• MDR Text Key: 176663988
• Report Number: 3008881809-2020-00005
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 07613252239345
• UDI-Public: 07613252239345
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K153658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/15/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 10/15/2021
• Device Catalogue Number: M0035422060
• Device Lot Number: 20941400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/30/2019
• Initial Date FDA Received: 01/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 58