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

Model Number	M0035421540
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 within a dispenser coil in the introducer sheath and product lot number was confirmed from the packaging.During visual inspection, it was noted that the proximal contact wire of subject device was intact.The subject coil delivery wire was seen to be kinked/bent.The subject main coil was returned detached and the distal tip was found intact.The main coil was also noted to be kinked/bent.Procedural fluid was also found on the returned subject device.Functional tests could not be carried out as the coil was detached.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 in catheter friction and as analyzed main coil kinked/bent, main coil prematurely detached/separated inside patient 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 delivery wire kinked/bent.
Event or Problem Description
It was reported that during a procedure to treat mca aneurysm.Physician placed guide catheter and then used guidewire to work with microcatheter to reach the lesion.During delivery, the subject coil experienced resistance at the tip of the microcatheter and could not be advanced.The physician replaced subject device with a new device and continued the procedure without clinical consequences to the patient.Analysis of the device revealed that the subject main coil was prematurely detached/separated during use.Therefore, based on this information the event is deemed reportable and emdr will be filed with an awareness date of 31-jul-2020.The pi will be assessed to reflect the decision change and emdr will be filed accordingly.
Event or Problem Description
During the analysis of the returned device, it was revealed that the subject main coil was prematurely detached/separated during use.No clinical consequences reported to the patient.

• Brand Name: TARGET 360 NANO 1.5MM 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: 10371291
• Report Number: 3008881809-2020-00233
• Device Sequence Number: 2889457
• Product Code: HCG
• UDI-Device Identifier: 04546540697998
• UDI-Public: 04546540697998
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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): 05/07/2021

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: 01/22/2022
• Device Model Number: M0035421540
• Device Catalogue Number: M0035421540
• Device Lot Number: 21162633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Initial Date Received by Manufacturer: 07/31/2020
• Supplement Date Received by Manufacturer: 05/05/2021
• Initial Report FDA Received Date: 08/05/2020
• Supplement Report FDA Received Date: 05/07/2021
• 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: EN-10 MICROCATHETER (UNKNOWN).; ENVOY 6F GUIDE CATHETER (UNKNOWN).; SYNCHRO GUIDEWIRE (STRYKER).; TARGET 360 DETACHABLE COIL (STRYKER).; EN-10 MICROCATHETER (UNKNOWN); ENVOY 6F GUIDE CATHETER (UNKNOWN); SYNCHRO GUIDEWIRE (STRYKER); TARGET 360 DETACHABLE COIL (STRYKER)
• Patient Age: 56 YR