MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 5MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036125150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not available to manufacturer.
Event or Problem Description
It was reported that during the procedure, the subject coil was filled as before, and there were no particular changes, but there was awareness that there was no 1: 1 movement during coil operation.An attempt was made to collect the subject coil, but it stretched.The physician made an attempt to collect from the subject coil from the femoral vessel on the same side and insert the snare from the contralateral side.The procedure was completed without clinical consequences to the patient.
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes), there are controls in the manufacturing process to ensure the product met specifications upon release.The device was received and the reported lot number was confirmed from the packaging.On visual/microscopic inspection, procedural fluids were noted in the non-stryker micro-catheter hub.The target coil was returned inserted in the non-stryker micro-catheter and could not be removed from the non-stryker micro-catheter.The main coil was extensively stretched and the suture was damaged.Unable to carry out functional test due to the severity of the damage noted to 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.The reported main coil stretched was confirmed during the analysis of the returned device.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.As per the additional information the device was confirmed to be in good condition during preparation/prior to use on the patient and it was prepared as per the dfu.The delivery wire was not wiped off with alcohol before inserting into inzone.The inzone dfu (nv0003933-01) states 'wipe the proximal end of the target detachable coil delivery wire with alcohol'.Blood was noted in the non-stryker catheter hub, which may indicate insufficient saline was used.This may have contributed to the reported event.This cannot be conclusively determined.It was seen that the main coil was severely stretched which would indicate significant friction was encountered in the microcatheter which may have led to the coil detaching/breaking during device withdrawal.The coil could not be removed from the non-stryker microcatheter.The internal diameter of the non -stryker catheter is unknown and the id could not be retrieved due to the device being stuck within.The as reported/as analyzed defects ¿main coil stretched', and 'patient medical or surgical intervention required' as well as the as analyzed ¿main coil suture damage' will be assigned procedural factors as these defects appear to be 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 or anatomical factors during use.
Event or Problem Description
It was reported that during the procedure, the subject coil was filled as before, and there were no particular changes, but there was awareness that there was no 1: 1 movement during coil operation.An attempt was made to collect the subject coil, but it stretched.The physician made an attempt to collect from the subject coil from the femoral vessel on the same side and insert the snare from the contralateral side.The procedure was completed without clinical consequences to the patient.

• Brand Name: TARGET XL 360 SOFT 5MM X 15CM
• 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: 11446427
• Report Number: 3008881809-2021-00118
• Device Sequence Number: 3497187
• Product Code: HCG
• UDI-Device Identifier: 07613327128291
• UDI-Public: 07613327128291
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/06/2023
• Device Model Number: M0036125150
• Device Catalogue Number: M0036125150
• Device Lot Number: 22498570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2021
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 05/28/2021
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 06/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention