MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 4MM X 10CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035474100
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Analysis of the returned device found that the main coil (subject device) was prematurely detached/separated during use.There were no clinical consequences to the patient reported as a result of this event and the procedure was completed successfully.
Additional Manufacturer Narrative
Due to the automated mes (manufacturing execution system), there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the main coil was seen to be detached/separated.The main coil was seen to be kinked/bent and stretched.The coil delivery wire was seen to be kinked/bend.The coil introducer sheath was not returned.Functional inspection was not carried out due to the damage noted to the 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 coil in catheter friction complaint could not be replicated during device analysis; however, the analysis results are consistent with the reported event.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information provided by the customer indicated that there was friction felt while advancing the coil within the microcatheter.The device was analyzed.The main coil was found to be detached/separated from the coil delivery wire, kinked/bent and stretched.The coil delivery was found to be kinked/bent.An assignable cause of procedural factors was assigned to the as reported ''coil in catheter friction'' and as analyzed "main coil stretched'¿, "main coil kinked/bent", "main coil prematurely detached/separated during use".As this complaint 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 was assigned to as analyzed "coil delivery wire kinked/bent" as the defect appears to be associated with handling of the product or portion of the product during the procedure.

• Brand Name: TARGET 360 SOFT 4MM X 10CM
• 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: 17910091
• Report Number: 3008881809-2023-00501
• Device Sequence Number: 6627152
• Product Code: HCG
• UDI-Device Identifier: 07613252192756
• UDI-Public: 07613252192756
• 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
• Report Date (Section B): 10/11/2023

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: 01/25/2025
• Device Catalogue Number: M0035474100
• Device Lot Number: 23428466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2023
• Initial Report FDA Received Date: 10/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2022
• 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: ENVOY GUIDE CATHETER (CODMAN); EXCELSIOR SL-10 MICROCATHETER (STRYKER); EXCELSIOR XT-27 MICROCATHETER (STRYKER); INZONE DETACHMENT SYSTEM (STRYKER); NEUROFORM EZ STENT (STRYKER); SYNCHRO GUIDEWIRE (STRYKER); TARGET COIL (STRYKER)
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 71 KG
• Patient Race: Asian