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

Catalog Number C-OF-1500

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017); Cut In Material (2454)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/27/2018

Event Type  Injury  

Manufacturer Narrative

Internal complaint number trackwise # (b)(4).The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.

Event Description

The hospital reported that during a coronary artery bypass procedure, axius coronary shunt piece broke off into the patient.The surgeon had the shunt in the artery and snagged it with a stitch.He pulled the shunt out of the artery and tried to cut the stitch out instead he cut the shunt in half.Half of the shunt fell into the open pleural field and was unable to located.They used another shunt and finished the procedure.Patient had a normal hospital course following and was discharged home in normal time without any related complications.

Manufacturer Narrative

Internal complaint number: (b)(4).The remaining piece of the device was returned to the factory for evaluation.A visual inspection was conducted.Signs of clinical use with evidence of blood on most parts of the remaining piece of the device were observed.It was observed that the shunt was cut in half.The other half of the shunt was not returned.Microscopic inspection showed a portion of the coil remained inside the lumen of the shunt.The broken shunt was detached from the thread connecting the tab.The tab was labeled with maquet 1.5.The replacement device used to complete the procedure was also returned; appeared intact and showed signs of clinical use and evidence of blood.The tab of the replacement device was labeled maquet 2.0.Based on the returned condition of the device and the information provided, the reported failure mode "break" was confirmed.A lot history record review was completed for lot number 25130550, which is the only lot number shipped to the account prior to the event date.There was no nonconformance which could be considered related to the reported event recorded in the lot history.

Manufacturer Narrative

(b)(4).

• Brand Name: AXIUS CORONARY SHUNT
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• Manufacturer (Section G): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 7363989
• MDR Text Key: 103269237
• Report Number: 2242352-2018-00258
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K010117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C-OF-1500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2018
• Is the Reporter a Health Professional?: No
• Device Age: YR
• Date Manufacturer Received: 05/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR