MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC AXIUS CORONARY SHUNT; CLAMP, VASCULAR

Model Number AXIUS CORONARY SHUNT 1.0 MM

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/26/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).A lot history record review was completed for the reported product lot number.There were no ncmr¿s for the reported lot number.Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.Device evaluated by mfr: device was discarded.

Event Description

The hospital reported that post use a coronary artery bypass procedure using axius coronary shunt 1.0 mm the flow coil was taken out, and after a while, the nurse noticed that the tip portion of the flow coil was missing.The customer could not find anything even searching all over the surgical field.When the anastomotic site was measured with a flow meter, a sufficient perfusion amount could be confirmed and it was judged that the tip section did not remain in the coronary artery, and the operation was completed.The hospital did not report any patient effects.

Manufacturer Narrative

(b)(4).

Event Description

The hospital reported that post use a coronary artery bypass procedure using axius coronary shunt 1.0 mm the flow coil was taken out, and after a while, the nurse noticed that the tip portion of the flow coil was missing.The customer could not find anything even searching all over the surgical field.When the anastomotic site was measured with a flow meter, a sufficient perfusion amount could be confirmed and it was judged that the tip section did not remain in the coronary artery, and the operation was completed.The hospital did not report any patient effects.

• Brand Name: AXIUS CORONARY SHUNT
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 8800380
• MDR Text Key: 151364785
• Report Number: 2242352-2019-00829
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• PMA/PMN Number: K010117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2020
• Device Model Number: AXIUS CORONARY SHUNT 1.0 MM
• Device Catalogue Number: OF-1000
• Device Lot Number: 25143840
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention