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

Catalog Number C-HSK-3038

Device Problem Device Slipped (1584)

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

Event Date 09/14/2017

Event Type  malfunction  

Manufacturer Narrative

Internal complaint number trackwise # (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 iii proximal seal system 3.8mm was used for proximal anastomoses.The umbrella had slipped out of the applicator just before the application after the loading process, carried out by the surgeon, controlled by the surgeon.A second shade was then used.For the second anastomosis the loading procedure was performed by the surgeon himself.The umbrella slipped out of the applicator just before application.Also this anastomosis could be carried out by the use of another umbrella, this time from a 4.3 system.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 iii proximal seal system 3.8mm was used for proximal anastomoses.The umbrella had slipped out of the applicator just before the application after the loading process, carried out by the surgeon, controlled by the surgeon.A second shade was then used.For the second anastomosis the loading procedure was performed by the surgeon himself.The umbrella slipped out of the applicator just before application.Also this anastomosis could be carried out by the use of another umbrella, this time from a 4.3 system.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

• 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: 6926027
• MDR Text Key: 90091361
• Report Number: 2242352-2017-00943
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K080169
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/24/2018
• Device Catalogue Number: C-HSK-3038
• Device Lot Number: 25131549
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 10/26/2017
• Date Device Manufactured: 03/23/2017
• 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: 66 YR