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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HS III PROXIMAL SEAL; CLAMP, VASCULAR
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MAQUET CARDIOVASCULAR LLC HS III PROXIMAL SEAL; CLAMP, VASCULAR Back to Search Results
Catalog Number C-HS-3045
Device Problems Fitting Problem (2183); Physical Resistance/Sticking (4012)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 03/22/2019
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 preparation for a coronary artery bypass procedure, hs iii proximal seal remained in the loader when the delivery system was pulled out.The customer felt some resistance when pulling out.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
Event Description
The hospital reported that during preparation for a coronary artery bypass procedure, hs iii proximal seal remained in the loader when the delivery system was pulled out.The customer felt some resistance when pulling out.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
Manufacturer Narrative
Internal complaint # trackwise # (b)(4).Autonumber # (b)(4).The device was returned to the factory for evaluation.The seal was not returned.A visual inspection was conducted.Signs of clinical use were observed.There were no signs of blood.The white plunger of the delivery device remained unpressed.The blue lock remained in the locked position.The delivery device was pulled out of the loading device for inspection.The dimensions of the delivery tube were taken.The inner diameter was measured at 0.196 inches, the outer diameter was measured at 0.2175 inches.The length of the delivery tube was measured at 2.498 inches.The measurement values recorded for the delivery tube were within the tolerance specifications.Based on the returned condition of the device and the evaluation results, the reported failure "fitting problem" was not confirmed.
 
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Brand Name
HS III PROXIMAL SEAL
Type of Device
CLAMP, VASCULAR
Manufacturer (Section D)
MAQUET CARDIOVASCULAR LLC
45 barbour pond drive
wayne NJ 07470
MDR Report Key8535337
MDR Text Key142748110
Report Number2242352-2019-00470
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
PMA/PMN Number
K130382
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/25/2019
Device Catalogue NumberC-HS-3045
Device Lot Number25142365
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/26/2019
Date Manufacturer Received06/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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