MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 2MM X 3CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number M0035442030

Device Problems Migration or Expulsion of Device (1395); Premature Separation (4045)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/20/2020

Event Type  malfunction  

Event Description

It was reported that during the procedure for cerebral aneurysm embolization, the subject coil and delivery wire was suspected of being stuck within the microcatheter when attempting to collect the delivery wire and was not collected.Physician attempted to advance the subject delivery wire again to the detach point and was met with strong resistance.Physician then felt the subject coil separate from the microcatheter and attempt the detachment process again to collect the delivery wire.Physician then noted that the framing coil that had been placed before had slightly moved and was displaced to the parent artery side.The procedure was then completed successfully.No clinical consequences were reported to the patient due to this event.No further information provided.

Manufacturer Narrative

D4 expiration date ¿ added.H3 device evaluated by mfg ¿updated.H3 summary attached - updated.H4 manufacturing date ¿ added.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.Device was returned for analysis, the subject device was returned and the lot number was not confirmed as the packaging was not returned with the device.A catheter was returned with the subject device.During visual inspection, it was observed that the proximal contact wire was kinked/bent.The subject coil delivery wire was severely kinked/bent and the main coil appeared to be electrolytically detached.The subject main coil was not returned.During functional testing, the coil friction in catheter test failed.The subject device was flushed with the returned catheter and would not flush.There was dried procedural fluid in the catheter hub and was subsequently submerged in warm water.An attempt to advance a patency mandrel in the catheter shaft was then carried out.The mandrel would still not advance, the catheter shaft was cut and the mandrel was advanced but there was no coil present in the catheter shaft.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 damage noted to the device would be indicative of the as reported defect.The as reported coil delivery wire jammed, coil delivery wire jammed, coil difficult to remove/withdraw from catheter, coil delivery wire friction, main coil prematurely detached/separated during use, main coil migration and device interaction with another device and as analyzed coil in catheter friction will be assigned procedural factors as the defect 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.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 will be assigned to the as analyzed coil proximal contact kinked/bent and coil delivery wire kinked/bent.

Event Description

It was reported that during the procedure for cerebral aneurysm embolization, the subject coil and delivery wire was suspected of being stuck within the microcatheter when attempting to collect the delivery wire and was not collected.Physician attempted to advance the subject delivery wire again to the detach point and was met with strong resistance.Physician then felt the subject coil separate from the microcatheter and attempt the detachment process again to collect the delivery wire.Physician then noted that the framing coil that had been placed before had slightly moved and was displaced to the parent artery side.The procedure was then completed successfully.No clinical consequences were reported to the patient due to this event.No further information provided.

• Brand Name: TARGET 360 NANO 2MM X 3CM
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 10553849
• MDR Text Key: 207539091
• Report Number: 3008881809-2020-00271
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 07613252600312
• UDI-Public: 07613252600312
• Combination Product (y/n): N
• PMA/PMN Number: K153658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/12/2022
• Device Model Number: M0035442030
• Device Catalogue Number: M0035442030
• Device Lot Number: 21808288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Date Manufacturer Received: 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MICROCATHETER (UNKNOWN).; MICROCATHETER (UNKNOWN)