MAUDE Adverse Event Report: MAQUET CV HS III PROXIMAL SEAL SYTEM 4.3MM; CLAMP, VASCULAR

Catalog Number C-HSK-3043

Device Problem Positioning Failure (1158)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/28/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).A lot history record review was completed for the reported product lot number.There was no nonconformance recorded in the lot history.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.

Event Description

The hospital reported that during a coronary artery bypass procedure, while inserting the heartstring iii proximal seal system 4.3mm, the device failed to deploy correctly and create a seal on the inner aortic wall.Several adjustment attempts were tried but a seal could not be achieved.The first device was removed and a second heartstring iii was inserted.The second device had a better outcome but a complete seal was not achieved.Finally the second device was removed and a cross clamp was used to stop the blood flow, so the procedure could continue.Approximately 1 liter of blood was lost during this time.Aortic diameter and patient blood pressure were within the required range per the ifu.

Manufacturer Narrative

(b)(4).

Event Description

The hospital reported that during a coronary artery bypass procedure, while inserting the heartstring iii proximal seal system 4.3mm, the device failed to deploy correctly and create a seal on the inner aortic wall.Several adjustment attempts were tried but a seal could not be achieved.The first device was removed and a second heartstring iii was inserted.The second device had a better outcome but a complete seal was not achieved.Finally the second device was removed and a cross clamp was used to stop the blood flow so the procedure could continue.Approximately 1 liter of blood was lost during this time.Aortic diameter and patient blood pressure were within the required range per the ifu.

• Brand Name: HS III PROXIMAL SEAL SYTEM 4.3MM
• 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: 7131735
• MDR Text Key: 95319269
• Report Number: 2242352-2017-01180
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080169
• 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
• Report Date: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/20/2018
• Device Catalogue Number: C-HSK-3043
• Device Lot Number: 25135033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/15/2018
• Date Device Manufactured: 10/20/2017
• 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