MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 2MM X 4CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035442040
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the acom aneurysm embolization case, physician prepared a micro catheter to fill the coil but on checking, he found that introducer sheath of the coil was kinked.He tried to push the coil but was unable to transfer it into the micro catheter.The coil was withdrawn and replaced with the another coil but he was still not able to insert the coil.Physician exchanged the micro catheter and tried to insert the new coil but was unable to do so.He then took the subject coil and inserted, resistance was encountered while advancing the coil inside the micro catheter and the coil got stretched and fractured.It was removed along with the micro catheter.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Event or Problem Description
It was reported that during the acom aneurysm embolization case, physician prepared a micro catheter to fill the coil but on checking, he found that introducer sheath of the coil was kinked.He tried to push the coil but was unable to transfer it into the micro catheter.The coil was withdrawn and replaced with the another coil but he was still not able to insert the coil.Physician exchanged the micro catheter and tried to insert the new coil but was unable to do so.He then took the subject coil and inserted, resistance was encountered while advancing the coil inside the micro catheter and the coil got stretched and fractured.It was removed along with the micro catheter.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.H3 device evaluated by mfg ¿updated.H3 summary attached - updated.D4 expiration date - added.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The device was received.The reported lot number was confirmed from the packaging label.During the visual inspection, the coil delivery wire was seen to be kinked/bent.There was dried blood seen within the sheath.The main coil was seen to be severely stretched and broken fractured.Functional testing was not performed due to the condition of the returned coil.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 delivery wire was found to be kinked/bent and main coil was found to be severely stretched.The main coil was found to be broken/fractured.Additional information provided by the customer indicated that big resistance was encountered when advancing the coil into microcatheter.The device was prepared for use as per the directions for use.Also, continuous flush was set up and maintained throughout the clinical procedure.An assignable cause of procedural factors will be assigned to the as reported & as analyzed 'main coil broken/fractured during use' and 'main col stretched' and to as reported 'coil in catheter friction' as these defects are 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 and/or anatomical factors during use.An assignable cause of handling damage will be assigned to the as analyzed 'coil delivery wire kinked/bent' since it is most likely that this damage occurred due to handling of delivery wire during the clinical procedure.

• Brand Name: TARGET 360 NANO 2MM X 4CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 12095320
• Report Number: 3008881809-2021-00283
• Device Sequence Number: 3979813
• Product Code: HCG
• UDI-Device Identifier: 07613252600299
• UDI-Public: 07613252600299
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/06/2023
• Device Model Number: M0035442040
• Device Catalogue Number: M0035442040
• Device Lot Number: 22494958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2021
• Initial Date Received by Manufacturer: 06/07/2021
• Supplement Date Received by Manufacturer: 08/16/2021
• Initial Report FDA Received Date: 06/30/2021
• Supplement Report FDA Received Date: 09/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ECHELON 10 MICRO CATHETER (MEDTRONICS); TARGET COILS (STRYKER)
• Patient Age: 65 YR
• Patient Weight: 68