• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CV HS III PROXIMAL SEAL CLAMP, VASCULAR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MAQUET CV HS III PROXIMAL SEAL CLAMP, VASCULAR Back to Search Results
Catalog Number C-HS-3045
Device Problem Difficult to Insert (1316)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/27/2017
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. The device has not yet been returned to maquet cardiac surgery for evaluation. We are following up with the customer for the return of the device. A supplemental report will be submitted if the device is received.
 
Event Description
The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal was not loaded into the delivery system properly. A replacement device was used to complete the procedure. The hospital did not report any patient effects.
 
Manufacturer Narrative
(b)(4). The hsk iii device was returned to the factory for evaluation. Signs of clinical use and no evidence of blood were observed. A visual inspection was conducted. The loading device was not returned and the seal was received outside of the delivery device. The seal and tension spring assembly were completely intact, the seal was not in a folded position. There were no signs of cracks or delamination observed on the seal. The slide lock on the delivery device was engaged and the plunger was not depressed. The following measurements were taken; the inner delivery tube diameter was measured at. 197 in. The outer diameter was measured at. 220 in. The length of the delivery tube was measured at 2. 51 in. The values recorded were within the tolerance specifications. Based upon the received condition of the device, the loading device was not returned and the seal was returned outside the delivery device without any evidence of the seal being folded, the complaint could not be confirmed.
 
Event Description
The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal was not loaded into the delivery system properly. A replacement device was used to complete the procedure. The hospital did not report any patient effects.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHS III PROXIMAL SEAL
Type of DeviceCLAMP, 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 Key6519019
MDR Text Key73798291
Report Number2242352-2017-00410
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K080169
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/25/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/25/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/14/2017
Device Catalogue NumberC-HS-3045
Device Lot Number25129543
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/27/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/24/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/14/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-