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U.S. Department of Health and Human Services

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

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MAQUET CV HS III PROXIMAL SEAL SYTEM 4.3MM CLAMP, VASCULAR Back to Search Results
Catalog Number C-HSK-3043
Device Problem Positioning Problem (3009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/05/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). A lot history record review was completed for the reported product lot number. There were no ncmr¿s for the reported lot number. 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 system 4. 3 mm umbrella was not mounted in the conveying device during the operation. A replacement device was used to complete the procedure. The hospital did not report any patient effects.
 
Event Description
The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 4. 3 mm umbrella was not mounted in the conveying device during the operation. A replacement device was used to complete the procedure. The hospital did not report any patient effects.
 
Manufacturer Narrative
(b)(4). The device was returned to the factory for investigation. Signs of clinical use and no evidence of blood were detected. Only the seal and tension spring assembly were returned. There were cracks observed on the outer coil and middle coil of the seal. There were no defects detected in regard the tension spring. Based on what was returned, and the condition of the components, the reported failure "fitting problem" is not confirmed, however the analyzed failure "cracked seal" is confirmed.
 
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Brand NameHS III PROXIMAL SEAL SYTEM 4.3MM
Type of DeviceCLAMP, VASCULAR
Manufacturer (Section D)
MAQUET CV
45 barbour pond drive
wayne NJ 07470
MDR Report Key7740793
MDR Text Key115908093
Report Number2242352-2018-00728
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
PMA/PMN Number
K080169
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 08/01/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/21/2019
Device Catalogue NumberC-HSK-3043
Device Lot Number25137371
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/05/2018
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received10/26/2018
Is This a Reprocessed and Reused Single-Use Device? No

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