MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 12MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035471230
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Analysis of the returned device found that the subject coil deployed prematurely during use.There were no clinical consequences to the patient reported as a result of this event.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the coil delivery wire was found to be kinked/bent and damaged.The main coil was found to be detached.The detachment seems to be mechanical.The main coil was found to be kinked/bent and stretched.The suture was found to be intact.Functional testing was not performed due to condition of 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.Additional information provided by the customer indicated that no damage was noted to the device packaging prior to opening, the device was flushed and prepared as per the dfu.During analysis, the main coil was noted to kinked/stretched and pre-maturely detached.In the case of this complaint, it is probable that the main coil sustained damage during advancement/retraction inside the microcatheter.It is then likely detached prematurely when the delivery wire was pulled back.An assignable cause of procedural factors will be assigned to the as reported coil in catheter friction and to as analyzed main coil stretched, main coil kinked/bent, and main coil prematurely detached/separated during use since these issues 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 and coil delivery wire damaged as it is most likely that the delivery wire kinked/damaged due to handling of the device during use.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the coil delivery wire was found to be kinked/bent and damaged.The main coil was found to be detached.The detachment seems to be mechanical.The main coil was found to be kinked/bent and stretched.The suture was found to be intact.Functional testing was not performed due to condition of 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.Additional information provided by the customer indicated that no damage was noted to the device packaging prior to opening, the device was flushed and prepared as per the dfu.During analysis, the main coil was noted to kinked/stretched and pre-maturely detached.In the case of this complaint, it is probable that the main coil sustained damage during advancement/retraction inside the microcatheter.It is then likely detached prematurely when the delivery wire was pulled back.An assignable cause of procedural factors will be assigned to the as reported coil in catheter friction and to as analyzed main coil stretched, main coil kinked/bent, and main coil prematurely detached/separated during use since these issues 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 and coil delivery wire damaged as it is most likely that the delivery wire kinked/damaged due to handling of the device during use.
Event or Problem Description
Analysis of the returned device found that the subject coil deployed prematurely during use.There were no clinical consequences to the patient reported as a result of this event.

• Brand Name: TARGET 360 SOFT 12MM X 30CM
• 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: 13579166
• Report Number: 3008881809-2022-00079
• Device Sequence Number: 20254070
• Product Code: HCG
• UDI-Device Identifier: 07613252192671
• UDI-Public: 07613252192671
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 02/22/2022

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: 10/14/2023
• Device Model Number: M0035471230
• Device Catalogue Number: M0035471230
• Device Lot Number: 22490261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2022
• Initial Report FDA Received Date: 02/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2020
• 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: EXCELSIOR SL-10 MICROCATHETER (STRYKER); TARGET COILS (STRYKER)
• Patient Age: 65 YR
• Patient Sex: Male