MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 5MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number M0036125150

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 10/28/2020

Event Type  Injury  

Manufacturer Narrative

Due to the automated mes system, there are controls in the manufacturing process to ensure the product met specifications upon release.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.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.As per the additional information the device was confirmed to be in good condition during preparation/prior to use on the patient and it was prepared as per the dfu.As the device was not returned for analysis, and a review and analysis of all available information fails to indicate an assignable cause, or a probable assignable cause for the reported event, an assignable cause of undeterminable will be assigned to this complaint.The device is not available to the manufacturer.

Event Description

It was reported that during the procedure subject coil was attempted to insert.Physician then noted that the subject device was stretched and proceeded to use a snare device to remove subject coil.The physician replaced it with a new device, and continued the procedure without clinical consequences to the patient.

• Brand Name: TARGET XL 360 SOFT 5MM X 15CM
• 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: 10901640
• MDR Text Key: 218184157
• Report Number: 3008881809-2020-00365
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 07613327128291
• UDI-Public: 07613327128291
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/04/2022
• Device Model Number: M0036125150
• Device Catalogue Number: M0036125150
• Device Lot Number: 21491501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2019
• 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: SNARE DEVICE (UNKNOWN)
• Patient Outcome(s): Required Intervention