MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR XT 27 MICROCATHETER ST 150; CATHETER, PERCUTANEOUS

Catalog Number M003XT2750810

Device Problem Component Missing (2306)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 10/24/2019

Event Type  Injury  

Event Description

It was reported that after the micro catheter (subject device) was advanced through the stenosis with the non-stryker guide wire in front of the internal carotid artery, the tip of the micro catheter was not confirmed under fluoroscopy.The marker at the tip of the subject micro catheter was found missing after procedure and it was confirmed that the marker remained implanted near internal carotid artery inside the patient's anatomy and was not able to be removed.The micro catheter was exchanged and the procedure was completed successfully.The patient's condition is stable.No further information is available.

Event Description

It was reported that after the micro catheter(subject device) was advanced through the stenosis with the non-stryker guide wire in front of the internal carotid artery, the tip of the micro catheter was not confirmed under fluoroscopy.The marker at the tip of the subject micro catheter was found missing after procedure and it was confirmed that the marker remained implanted near internal carotid artery inside the patient's anatomy and was not able to be removed.The micro catheter was exchanged and the procedure was completed successfully.The patient's condition is stable.No further information is available.

Manufacturer Narrative

Expiration date - added.Device evaluated by mfg - updated.Summary attached - updated.Manufacturing date ¿ added.The device history record review confirms that the device met all material, assembly and performance specifications.The subject device was returned.Visual analysis revealed that the ro marker was missing from the device and the distal 30 cm section of the micro catheter was flattened and kinked.Functional analysis could not be performed based on damage to the product.The reported issue is covered in the device directions for use.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 revealed that the device was stated to be in good condition, it was prepared according to the dfu specifications, and the patient's anatomy was very tortuous.It is probable that the micro catheter was damaged during navigation through the tortuous anatomy causing the damage noted to the distal section of the microcatheter and dislodging the ro marker band.Therefore, an assignable cause of procedural factors was assigned to the reported event.

• Brand Name: EXCELSIOR XT 27 MICROCATHETER ST 150
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 9324917
• MDR Text Key: 166793955
• Report Number: 3008881809-2019-00345
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 04546540698131
• UDI-Public: 04546540698131
• Combination Product (y/n): N
• PMA/PMN Number: K113778
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/21/2021
• Device Catalogue Number: M003XT2750810
• Device Lot Number: 20709556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Initial Date Manufacturer Received: 10/24/2019
• Initial Date FDA Received: 11/14/2019
• Supplement Dates Manufacturer Received: 12/18/2019
• Supplement Dates FDA Received: 12/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CHIKAI GUIDEWIRE(MEDTRONIC)
• Patient Outcome(s): Other; Required Intervention