MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 STANDARD 12MM X 45CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036101240
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/06/2020
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.The device was returned with the introducer sheath.The lot number was confirmed with the packaging returned with the device.On visual inspection, the main coil was returned detached.The proximal contact wire was intact.The coil delivery wire was severely kinked/bent.The distal tip was found to be intact.The main coil was stretched.The suture was damaged.Functional testing could not be carried out as the main 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.Additional information provided by the customer indicated that preparation/set-up was performed as per the dfu, continuous flush was maintained, the coil was not advanced or retracted with force, and there was no allegation against the micro catheter.Analysis of the returned device revealed the main coil was detached from the delivery wire.The delivery wire was found to be kinked and the main coil was stretched with suture damage.In the case of this complaint, it is most likely that the coil stretched and was mechanically detached when it was pushed/pulled against the reported resistance in the micro catheter.An assignable cause of procedural factors will be assigned to the as reported and as analyzed events since these issues 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 and/or anatomical factors during use.The as analyzed coil delivery wire kinked bent will be assigned handling damage as the issue is due to handling of the product or portion of the product during the clinical procedure, upon removal of the product from the packaging, or preparation of the product prior to use.
Event or Problem Description
It was reported that during the procedure when the subject coil was advancing within the micro catheter, resistance was encountered.The physician retracted both the subject coil and micro catheter.On checking the subject coil outside the patient anatomy, it was found to be stretched.Analysis of the device revealed that the subject mail coil prematurely detached/separated during use.There was no clinical consequence to the patient as a result of this event.

• Brand Name: TARGET XL 360 STANDARD 12MM X 45CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• MDR Report Key: 10383769
• Report Number: 3008881809-2020-00236
• Device Sequence Number: 19430937
• Product Code: HCG
• UDI-Device Identifier: 04546540711281
• UDI-Public: 04546540711281
• Combination Product (Y/N): N
• Initial Reporter Country: JP
• 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): 08/10/2020

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: 08/14/2022
• Device Model Number: M0036101240
• Device Catalogue Number: M0036101240
• Device Lot Number: 21643456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/14/2020
• Initial Report FDA Received Date: 08/10/2020
• 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: MICROCATHETER (UNKNOWN MANUFACTURER)