MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HST III SEAL (4.5MM); CLAMP, VASCULAR

Model Number HST III SEAL (4.5MM), 5-PACK

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 12/02/2019

Event Type  Injury  

Manufacturer Narrative

Trackwise id# (b)(6).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 discarded.

Event Description

The hospital reported that during a coronary artery bypass procedure using hst iii seal (4.5mm).As usual, the main body was set and the umbrella was opened, but it was not hemostatic and the field of vision could not be secured.They inserted the heart string as usual and opened the umbrella, but couldn't stop bleeding because it was not in close contact, and couldn't secure the field of view of the operative field.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

Trackwise id (b)(6).Updated sections: e1, g4, g7, h2, h3, h10.

Event Description

He hospital reported that during a coronary artery bypass procedure using hst iii seal (4.5mm).As usual, the main body was set and the umbrella was opened, but it was not hemostatic and the field of vision could not be secured.They inserted the heart string as usual and opened the umbrella, but couldn't stop bleeding because it was not in close contact, and couldn't secure the field of view of the operative field.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

• Brand Name: HST III SEAL (4.5MM)
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 9510054
• MDR Text Key: 174346077
• Report Number: 2242352-2019-01419
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• PMA/PMN Number: K130382
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/18/2020
• Device Model Number: HST III SEAL (4.5MM), 5-PACK
• Device Catalogue Number: HS-3045
• Device Lot Number: 25147638
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 01/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention