MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 8MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number M0036128300

Device Problem Premature Activation (1484)

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

Event Date 09/04/2023

Event Type  malfunction  

Event Description

It was reported that during the procedure, the coil (subject device) detached prematurely within the microcatheter.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

Event Description

It was reported that during the procedure, the coil (subject device) detached prematurely within the microcatheter.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

Manufacturer Narrative

B1 adverse event/product problem - corrected - corrected - no product problem.H1 type of reportable event - corrected - no malfunction.D4 expiration date - added h4 manufacturing date ¿ added h3 device evaluated by mfg ¿updated h3 summary attached - 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.The device was returned, and the reported lot number was not confirmed as the packaging was not returned with the device.During visual inspection, the coil delivery wire was seen to be kinked.The main coil was seen to be attached and severely stretched and the main coil suture was damaged.The coil introducer sheath was not returned.The reported event is covered in the device direction 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 product was returned.The reported main coil prematurely detached/separated during use was not confirmed during analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.The device was prepared for use as per the dfu.There was no damage noted to the packaging prior to opening the packaging.Continuous flush was maintained throughout the procedure.During analysis, the coil delivery wire was seen to be kinked in two locations.The main coil and suture were both damaged but the main coil was still attached.An assignable cause of not confirmed will be assigned to the as reported event of main coil prematurely detached/separated during use as the event was not confirmed during the analysis.An assignable cause of handling damage will be assigned to the as analyzed event of coil delivery wire kinked/bent as the issue is due to handling of the product or portion of the product during the clinical procedure.An assignable cause of procedural factors will be assigned to the as analyzed events of main coil stretched and main coil suture damage 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 the manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.

• Brand Name: TARGET XL 360 SOFT 8MM X 30CM
• 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: 17881926
• MDR Text Key: 325071363
• Report Number: 3008881809-2023-00480
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 07613327004649
• UDI-Public: 07613327004649
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M0036128300
• Device Lot Number: 24025291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2022
• 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: SL-10 MICROCATHETER (STRYKER)