MAUDE Adverse Event Report: MAQUET CV HS III PROXIMAL SEAL SYTEM 3.8MM; CLAMP, VASCULAR

Catalog Number C-HSK-3038

Device Problem Insufficient Information (3190)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/10/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 post procedure for a coronary artery bypass procedure, heartstring iii seal system user left a piece of the device in the patient.The hospital did not report any patient effects.Heartstring was deployed, no product malfunction.After product deployment and successful anastomosis, tension spring was left behind in chest cavity.Per rep foreign object was removed.The tension spring was removed by following hospital's "removal of foreign object procedure".No consequences or impact to the patient.

Manufacturer Narrative

(b)(4).A lot history record review was completed for lots 25129853, 25130631 and 25131453, the last 3 lots shipped to the account prior to the event date.There was no nonconformance recorded in the lot history.

Event Description

The hospital reported post procedure for a coronary artery bypass procedure, heartstring iii seal system user left a piece of the device in the patient.The hospital did not report any patient effects.Heartstring was deployed, no product malfunction.After product deployment and successful anastomosis, tension spring was left behind in chest cavity.Per rep foreign object was removed.The tension spring was removed by following hospital's "removal of foreign object procedure".No consequences or impact to the patient.

• Brand Name: HS III PROXIMAL SEAL SYTEM 3.8MM
• 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: 6680443
• MDR Text Key: 78804763
• Report Number: 2242352-2017-00638
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: C-HSK-3038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 08/03/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 72