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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HSK III SYSTEM (3.8MM); CLAMP, VASCULAR
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MAQUET CARDIOVASCULAR LLC HSK III SYSTEM (3.8MM); CLAMP, VASCULAR Back to Search Results
Model Number HST III SYSTEM (3.8MM)
Device Problem Failure to Unfold or Unwrap (1669)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/11/2020
Event Type  Injury  
Manufacturer Narrative
(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 a coronary artery bypass procedure, hst iii system (3.8mm) seal was properly deployed but the seal fail to unfold in the shape of an umbrella and fell into the hole.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, hst iii system (3.8mm) seal was properly deployed but the seal fail to unfold in the shape of an umbrella and fell into the hole.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
Manufacturer Narrative
Corrected section: h-3 device not eval provide code: from "other" to "device evaluation anticipated, but not yet begun." (b)(4).
 
Manufacturer Narrative
Nternal complaint number: (b)(4).The lot # 25153082 history record review was completed.There were no ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.The device was returned to the factory on 20nov2020 for evaluation.Photograph from the account shows that there was blood was present in the delivery device and the seal.Speck of blood observed on the loading device.The blue slide lock was dis-engaged and the plunger was completely depressed.The seal was extended outside of the delivery device and did not appear to be folded.The returned device was investigated on 14dec2020.A visual inspection was conducted.Signs of clinical use and blood was observed on the loading device, delivery device and seal.Blood was present in the delivery device, indicating deployment in to the aorta.The blue slide lock was dis-engaged and the plunger was completely depressed.The anchor and tension spring assembly remained inside the delivery device in the pre-deployed position.The seal was extended outside the tube and did not appear to be folded.The seal was inspected.The tether remained uncut and attached to the seal and tension spring.Measurements were unable to be taken; the inner delivery tube contained a heavy amount of dried blood/tissue.Based on the returned condition of the device, the reported failure "failure to unfold or unwrap" was not confirmed.
 
Event Description
The hospital reported that during a coronary artery bypass procedure, hst iii system (3.8mm) seal was properly deployed but the seal fail to unfold in the shape of an umbrella and fell into the hole.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
Manufacturer Narrative
H6 corrections: investigation findings: changed to no device problem found - 213.Investigation conclusions: no problem detected - 67.Internal complaint number: (b)(4).
 
Event Description
The hospital reported that during a coronary artery bypass procedure, hst iii system (3.8mm) seal was properly deployed but the seal fail to unfold in the shape of an umbrella and fell into the hole.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
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Brand Name
HSK III SYSTEM (3.8MM)
Type of Device
CLAMP, VASCULAR
Manufacturer (Section D)
MAQUET CARDIOVASCULAR LLC
45 barbour pond drive
wayne NJ 07470
MDR Report Key10937981
MDR Text Key219307139
Report Number2242352-2020-01059
Device Sequence Number1
Product Code DXC
UDI-Device Identifier00607567700314
UDI-Public00607567700314
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,Followup,Followup
Report Date 12/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/19/2021
Device Model NumberHST III SYSTEM (3.8MM)
Device Catalogue NumberC-HSK-3038
Device Lot Number25153082
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/20/2020
Was the Report Sent to FDA? Yes
Date Manufacturer Received03/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age74 YR
Patient Weight83
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