MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 20MM X 50CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number M0036182050

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/29/2019

Event Type  malfunction  

Manufacturer Narrative

The subject device not returned.

Event Description

It was reported that when advancing the subject 5th coil through the microcatheter, resistance was encountered and the coil got stuck; therefore, the coil was removed.Upon removal from the microcatheter, the subject coil was broken.Another coil was used to complete the procedure.No patient consequences reported due to this event.

Manufacturer Narrative

Expiration date: added.Manufacturing date: added.The electronic device history record (edhr) review confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, visual, dimensional and functional testing could not be performed.The reported issue is covered in the device directions for use.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 product was not returned, however, additional information indicated that intermittent flush was used during the procedure and it is likely that the failure to apply continues flush may have caused the reported friction leading to the reported fracture of the main coil.As per the dfu "warning: in order to achieve optimal performance of the target detachable coil system and to reduce the risk of thromboembolic complications, it is critical that a continuous infusion of appropriate flush solution be maintained between a) the femoral sheath and guiding catheter, b) the 2-tip microcatheter and guiding catheters, and c) the 2-tip microcatheter and stryker neurovascular guidewire and delivery wire.Continuous flush also reduces the potential for thrombus formation on, and crystallization of infusate around, the detachment zone of the target detachable coil." the investigation confirmed that there was an act or omission of an act that could have resulted in a different medical device response than intended by the manufacturer and/or expected by the user.Therefore, an assignable cause of user error has been assigned to this event.

Event Description

It was reported that when advancing the subject 5th coil through the microcatheter, resistance was encountered and the coil got stuck; therefore, the coil was removed.Upon removal from the microcatheter, the subject coil was broken.Another coil was used to complete the procedure.No patient consequences reported due to this event.

• Brand Name: TARGET XXL 360 20MM X 50CM
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 9079072
• MDR Text Key: 159369789
• Report Number: 3008881809-2019-00279
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 07613327128345
• UDI-Public: 07613327128345
• Combination Product (y/n): N
• PMA/PMN Number: K161429
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/30/2019

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: 02/17/2022
• Device Catalogue Number: M0036182050
• Device Lot Number: 21234614
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/30/2019
• Initial Date FDA Received: 09/17/2019
• Supplement Dates Manufacturer Received: 10/09/2019
• Supplement Dates FDA Received: 10/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PROGRATE MICROCATHETER (TERUMO MEDICAL)