MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 2MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035422060
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an aneurysm treatment case, subject coil got prematurely deployed in microcatheter.There were no clinical consequences to the patient reported as a result of this event and the procedure was completed successfully.
Additional Manufacturer Narrative
B1 adverse event and product problem ¿ corrected ¿ no product problem b5 executive summary - updated d4 expiration date - added d9 product available to stryker ¿ updated d9 returned to manufacturer on ¿updated h1 type of reportable event - no malfunction h3 device evaluated by mfg ¿updated h4 manufacturing date ¿ added g4 pma/510(k - corrected d4 gtin - corrected due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, it was observed that subject coil was returned without the transport hoop.The subject coil delivery wire was seen to be kinked/bent in multiple areas and the main coil was seen to be stretched.The main coil suture was seen to be damaged.Functional testing was not required as the event was not confirmed from the visual inspection 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.The reported event was not confirmed based on the device analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.The complaint reported that the subject main coil deployed in the catheter.During analysis, the subject coil delivery wire was seen to be kinked, the main coil was still attached but extremely stretched and the suture damaged.It is likely that the subject coil was thought to have detached due to the main coil stretching.An assignable cause of not confirmed will be assigned to the as reported code main coil prematurely detached/separated during use as the defect was not confirmed during analysis.An assignable cause of procedural factors will be assigned to the as analyzed main coil stretched and main coil suture damaged these defects appears 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 factors during use.An assignable cause of handling damage will be assigned to the as analyzed code coil delivery wire kinked/bent as the defect appears to be associated with handling of the product or portion of the product during preparation.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
Event or Problem Description
It was reported that during an aneurysm treatment case, subject coil got prematurely deployed in microcatheter.There were no clinical consequences to the patient reported as a result of this event and the procedure was completed successfully.The subject coil was returned for analysis.The coil was examined, and it was discovered that the reported event of the subject coil being prematurely detached/separated during use was not confirmed.The subject main coil was seen to be stretched, and coil delivery wire was seen to be kinked/bent in multiple areas.The subject main coil suture was seen to be damaged.

• Brand Name: TARGET 360 ULTRA 2MM X 6CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 19875895
• Report Number: 3008881809-2024-00342
• Device Sequence Number: 20646440
• Product Code: HCG
• UDI-Device Identifier: 07613252239345
• UDI-Public: (01)07613252239345(17)251120(10)24013278
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K112385
• 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): 10/08/2024

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: 11/20/2025
• Device Catalogue Number: M0035422060
• Device Lot Number: 24013278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/09/2024
• Supplement Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 07/31/2024
• Supplement Report FDA Received Date: 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ECHLEON 10 MICROCATHETER (MEDTRONIC).
• Patient Sex: Unknown