MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 STANDARD 10MM X 40CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number M0036101040

Device Problem Premature Separation (4045)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/15/2024

Event Type  malfunction  

Event Description

It was reported that during the procedure the subject coil detached prematurely inside the catheter.No further information available.

Manufacturer Narrative

H3 other text : the device is not available to the manufacturer.

Event Description

It was reported that during the procedure the subject coil detached prematurely inside the catheter.No further information available.Update: it was reported that during the procedure the subject coil was impossible to fit it into the microcatheter.When the microcatheter was withdrawn, the subject coil was found to be blocked inside.There was 20 minutes surgical delay.The procedure was completed successfully with no clinical consequences to the patient.

Manufacturer Narrative

B5 executive summary - updated.F10 / h6 health impact code grid - health effect - impact code ¿ updated.H4 manufacturing date ¿ added.H3 device evaluated by mfg ¿updated.H3 summary attached - updated.Section d catalog#, product long description, and gtin# - corrected.D4 expiration date - added.D9 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.Due to the automated (manufacturing execution system) 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 seen to be kinked/bent in multiple areas.The main coil was seen to be stretched.The main coil suture was seen to be damaged.The coil delivery wire was seen to be broken/fractured.The coil introducer sheath was seen to be damaged.A mandrel was advanced through the returned catheter.Using a blade the catheter was then cut open and most of the main coil was retrieved from the catheter.Functional testing was not performed.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 during analysis; however, the device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.An assignable cause of handling damage will be assigned to the analyzed damage of the coil delivery wire broken/fractured during use and to coil delivery wire kinked/bent, 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.An assignable cause of procedural factors was assigned to the analyzed coil introducer sheath damaged as well as to the main coil suture damaged and main coil stretched 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 not confirmed will be assigned to the reported event of the main coil prematurely detached/separated during use and coil jammed as the event was not confirmed during the analysis.

• Brand Name: TARGET XL 360 STANDARD 10MM X 40CM
• Type of Device: 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: 18559979
• MDR Text Key: 333463429
• Report Number: 3008881809-2024-00023
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 04546540711274
• UDI-Public: 04546540711274
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K153658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M0036101040
• Device Lot Number: 24510860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MICROCATHETER (UNKNOWN).