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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HST III SEAL (4.5MM), 5-PACK CLAMP, VASCULAR

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MAQUET CARDIOVASCULAR LLC HST III SEAL (4.5MM), 5-PACK CLAMP, VASCULAR Back to Search Results
Model Number HST III SEAL (4.5MM), 5-PACK
Device Problem Fitting Problem (2183)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/26/2020
Event Type  malfunction  
Manufacturer Narrative
Trackwise id# (b)(4). 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 preparation for a coronary artery bypass procedure using hst iii seal (4. 5mm), 5-pack, when i tried to use heartstring iii (ref: hs-3045 lot: 25149957) at the time of opcab, they loaded the seal and tried to pull it out, but they could not pull out the main body. Judging that it was a defective product, they abandoned the use of this system and performed a central anastomosis with another device.
 
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Brand NameHST III SEAL (4.5MM), 5-PACK
Type of DeviceCLAMP, VASCULAR
Manufacturer (Section D)
MAQUET CARDIOVASCULAR LLC
45 barbour pond drive
wayne NJ 07470
Manufacturer (Section G)
MAQUET CARDIOVASCULAR LLC
45 barbour pond drive
wayne NJ 07470
Manufacturer Contact
dorota wolpiuk
45 barbour pond drive
wayne, NJ 07470
MDR Report Key11031603
MDR Text Key222774974
Report Number2242352-2020-01139
Device Sequence Number1
Product Code DXC
UDI-Device Identifier00607567700307
UDI-Public00607567700307
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K130382
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/16/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/29/2021
Device Model NumberHST III SEAL (4.5MM), 5-PACK
Device Catalogue NumberHS-3045
Device Lot Number25149957
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/30/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received01/14/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/29/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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