MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK AXS UNIVERSAL ASPIRATION TUBING; PUMP, PORTABLE ASPIRATION (MANUAL OR POWERED)

Model Number 077.0193

Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 12/17/2020

Event Type  Injury  

Manufacturer Narrative

Device is not available to manufacturer.

Event Description

It was reported that during the procedure, the physician tried to remove the aspiration tubing (subject device) from the microcatheter to manually syringe aspirate.During this attempt, the subject tubing connector got stuck in the microcatheter and broke.Additional device (tweezer) was used as a medical intervention to remove the broken part of tube connector from the patient's anatomy.During the removal process, it was reported that the pump was off and the clamp was closed.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

Manufacturer Narrative

Based on further review of the complaint details, the aspiration tube (subject device) was broken inside the catheter hub.This break/damage of the subject aspiration tube will not likely cause or contribute to a death or serious injury if this malfunction recur.Based on the information, this event does not meet reporting criteria anymore and the reportability will be changed from reportable to non-reportable with an awareness date of 19-feb-2021.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.

Event Description

It was reported that during the procedure, the physician tried to remove the aspiration tubing (subject device) from the microcatheter to manually syringe aspirate.During this attempt, the subject tubing connector got stuck in the microcatheter and broke.Additional device (tweezer) was used as a medical intervention to remove the broken part of tube connector from the patient's anatomy.During the removal process, it was reported that the pump was off and the clamp was closed.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: AXS UNIVERSAL ASPIRATION TUBING
• Type of Device: PUMP, PORTABLE ASPIRATION (MANUAL OR POWERED)
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 11228319
• MDR Text Key: 228606157
• Report Number: 3008881809-2021-00049
• Device Sequence Number: 1
• Product Code: BTA
• UDI-Device Identifier: 07612367052719
• UDI-Public: 07612367052719
• Combination Product (y/n): N
• PMA/PMN Number: K170329
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 077.0193
• Device Catalogue Number: 077.0193
• Device Lot Number: W-032486
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CATALYST 6 MICROCATHETER (STRYKER); INFINITY GUIDEWIRE (STRYKER); STENT RETRIEVER (UNKNOWN MANUFACTURER); TRANSEND PLATINUM GUIDEWIRE (STRYKER); TWEEZER (UNKNOWN MANUFACTURER); CATALYST 6 MICROCATHETER (STRYKER); INFINITY GUIDEWIRE (STRYKER); STENT RETRIEVER (UNKNOWN MANUFACTURER); TRANSEND PLATINUM GUIDEWIRE (STRYKER); TWEEZER (UNKNOWN MANUFACTURER)
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR