MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 1.5MM X 4CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number M0035421540

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/11/2019

Event Type  malfunction  

Manufacturer Narrative

Manufacturing date: added.Device evaluated by mfg: updated.Expiration date: added.Product available to stryker: updated.Returned to manufacturer on: updated.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.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 device was returned for analysis and the coil was found jammed inside the sl 10 microcatheter, kinked/bent, stretched and detached from the delivery wire.In the case of this complaint it is most likely that the coil kinked during manipulation of the coil against friction.Then the coil got jammed inside the catheter and upon attempted withdrawal, the coil stretched and then detached from the delivery wire.This complaint appears to be associated with a product that met design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.Therefore an assignable cause of procedural factors will be assigned to the reported and analyzed events.

Event Description

It was reported that during the procedure, the subject coil got stuck inside the micro catheter.The physician removed the subject coil and micro catheter from the patient anatomy and completed the procedure successfully with another product.No clinical consequences were reported to the patient due to this event.Analysis of the device revealed that the main coil prematurely detached/separated inside patient; therefore, based on this information the event is deemed reportable with an awareness date of 24-mar-2020.

Event Description

It was reported that during the procedure, the subject coil got stuck inside the micro catheter.The physician removed the subject coil and micro catheter from the patient anatomy and completed the procedure successfully with another product.No clinical consequences were reported to the patient due to this event.Analysis of the device revealed that the main coil prematurely detached/separated inside patient; therefore, based on this information the event is deemed reportable with an awareness date of (b)(6)2020.Additional information was received on (b)(6)2020 that during the procedure, the physician placed the subject coil at the lesion and used a detachment system device to successfully detach the subject coil.The physician withdrew the subject coil delivery wire from the patient anatomy.However, when he went to remove the micro catheter from the aneurysm, the subject coil was stuck in the distal tip of the micro catheter.Physician removed the subject coil and micro catheter together from the patient, replaced with new devices and continued without the procedure without consequence to the patient.The physician did not take any action/ intervention due to this event.There was no reported permanent impairment of a body function or permanent damage to a body structure, no medical or surgical intervention to prevent permanent impairment of a body function or structure was performed and the event was not life threatening.There was no information to reasonably suggest that this type of malfunction would likely cause or contribute to a death or serious injury if the malfunction were to reoccur.Therefore, this event does not meet the requirements of a reportable event.

Manufacturer Narrative

B1: adverse event/product problem: not applicable b5 executive summary - updated h1: type of reportable event: not applicable h2 - follow up type - updated h10: additional mfg narrative type non-reportable rationale: due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The device was returned jammed within the micro catheter.The lot number was confirmed with the returned packaging.The coil was found detached from the delivery wire.The delivery wire was not returned.On visual inspection, the coil was removed from the catheter and inspected.The coil was found kinked/bent and stretched.The distal tip ball was intact.The micro catheter was inspected and no defects were noted.Functional inspection: functional inspection could not be performed due to the condition of the returned device.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.Additional information states the physician "used an in zone.When he deployed the coil, there was nothing unusual, so he detached it as he would any coil and got the 3 beeps indicating the coil was properly detached.However, when he went to remove the micro catheter from the aneurysm, the coil was stuck to the distal tip".The device was returned for analysis and the coil was found jammed inside the micro catheter, kinked/bent, stretched.In the case of this complaint it is most likely anatomical or procedural factors encountered during the detachment process resulted in the coil partially detaching from the target device.Then the coil got jammed inside the catheter and upon attempted withdrawal, the coil stretched and then detached fully from the delivery wire.This complaint 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 factors during use.Therefore an assignable cause of procedural factors will be assigned to the event.The physician did not take any action/ intervention due to this event.There was no reported permanent impairment of a body function or permanent damage to a body structure, no medical or surgical intervention to prevent permanent impairment of a body function or structure was performed and the event was not life threatening.There was no information to reasonably suggest that this type of malfunction would likely cause or contribute to a death or serious injury if the malfunction were to reoccur.Therefore, this event does not meet the requirements of a reportable event.

• Brand Name: TARGET 360 NANO 1.5MM X 4CM
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• MDR Report Key: 9967928
• MDR Text Key: 188657467
• Report Number: 3008881809-2020-00104
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 04546540697998
• UDI-Public: 04546540697998
• 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: 05/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/16/2021
• Device Model Number: M0035421540
• Device Catalogue Number: M0035421540
• Device Lot Number: 21101961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Date Manufacturer Received: 04/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SL-10 MICROCATHETER (STRYKER)