MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HSK III SYSTEM; CLAMP, VASCULAR

Model Number HST III SYSTEM (3.8MM)

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 06/24/2019

Event Type  Injury  

Manufacturer Narrative

Trackwise id # (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 was discarded.

Event Description

Summary: the hospital reported that during a coronary artery bypass procedure using hst iii system (3.8mm) , while suturing the heartstring, they put a suture through the seal.Although they were using the correct technique, the suture passed through without them knowing.Up on pulling the string out, the suture site was torn and the patient bled from the area.He had the blood pressure lowered and was able to repair the site without further incident.The hospital did not report any patient effects.

Event Description

Summary: the hospital reported that during a coronary artery bypass procedure using hst iii system (3.8mm) , while suturing the heartstring, they put a suture through the seal.Although they were using the correct technique, the suture passed through without them knowing.Up on pulling the string out, the suture site was torn and the patient bled from the area.He had the blood pressure lowered and was able to repair the site without further incident.The hospital did not report any patient effects.

Manufacturer Narrative

Corrected section: h1-changed to serious injury trackwise # (b)(4).

Manufacturer Narrative

Trackwise#: (b)(4).Updated sections: g4 (pma/510k), h2 (if follow-up, what type), h6, h10.

Event Description

Summary: the hospital reported that during a coronary artery bypass procedure using hst iii system (3.8mm) , while suturing the heartstring, they put a suture through the seal.Although they were using the correct technique, the suture passed through without them knowing.Up on pulling the string out, the suture site was torn and the patient bled from the area.He had the blood pressure lowered and was able to repair the site without further incident.The hospital did not report any patient effects.

• Brand Name: HSK III SYSTEM
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 8796608
• MDR Text Key: 151258319
• Report Number: 2242352-2019-00813
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/13/2020
• Device Model Number: HST III SYSTEM (3.8MM)
• Device Catalogue Number: HSK-3038
• Device Lot Number: 25146521
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 11/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention