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

Catalog Number M0035423100

Device Problem Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/31/2017

Event Type  malfunction  

Manufacturer Narrative

The subject device is not available.

Event Description

It was reported that during the coil embolization of the carotid cavernous fistula (ccf), the coil was detached prematurely inside the microcatheter.The coil was successfully removed along with the microcatheter and the procedure was completed successfully using another device.There were no clinical consequences reported to the patient.

Manufacturer Narrative

The device history record (dhr) review, there is no indication that the device, labelling or packaging failed to meet its specifications when released.Analysis of the return device revealed that the proximal contact and the delivery wire was kinked lily due to handling.The coil was found kinked and also noted to be physically broken/ fractured from the detachment zone.During the functional testing, the main coil was advanced forward through the introducer sheath following flush without any issues.Information available indicated that no damage was noted to the device prior to use and the device was prepared as per device direction for use (dfu).However, due to procedural and/or anatomical factors during use, the device performance was limited, therefore an assignable cause of operational context has been assigned to the reported coil premature deployment and observed damages.

Event Description

It was reported that during the coil embolization of the carotid cavernous fistula (ccf), the coil was detached prematurely inside the microcatheter.The coil was successfully removed along with the microcatheter and the procedure was completed successfully using another device.There were no clinical consequences reported to the patient.

Manufacturer Narrative

Expiration date: added.Manufacturing date: added.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The subject device was not returned; therefore, physical as well as a functional evaluation could not be performed.As per additional information no damage was noted to the device prior to use and the device was prepared as per device direction for use(dfu) for this product.Therefore it is probable that the coil prematurely detached during the clinical procedure limiting the performance of the device during the clinical procedure.Therefore, an assignable cause of operational context has been assigned to this investigation.

Event Description

It was reported that during the coil embolization of the carotid cavernous fistula (ccf), the coil was detached prematurely inside the microcatheter.The coil was successfully removed along with the microcatheter and the procedure was completed successfully using another device.There were no clinical consequences reported to the patient.

• Brand Name: TARGET 360 ULTRA 3MM X 10CM
• 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: 7073520
• MDR Text Key: 93476456
• Report Number: 3008881809-2017-00503
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K112385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: M0035423100
• Device Lot Number: 19567365
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2017
• 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: 21 YR