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

Catalog Number C-HSK-3043

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 05/24/2018

Event Type  malfunction  

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, hs proximal seal system seal remained in loading device.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

(b)(4).

Event Description

The hospital reported that during a coronary artery bypass procedure, hs proximal seal system seal remained in loading device.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

• 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: 7606356
• MDR Text Key: 111903195
• Report Number: 2242352-2018-00557
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/20/2018
• Device Catalogue Number: C-HSK-3043
• Device Lot Number: 25136209
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: YR
• Initial Date Manufacturer Received: 05/24/2018
• Initial Date FDA Received: 06/15/2018
• Supplement Dates Manufacturer Received: 08/10/2018
• Supplement Dates FDA Received: 08/31/2018
• Date Device Manufactured: 12/20/2017
• 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 Age: 67 YR