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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CV HS III PROXIMAL SEAL SYTEM 3.8MM CLAMP, VASCULAR

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MAQUET CV HS III PROXIMAL SEAL SYTEM 3.8MM CLAMP, VASCULAR Back to Search Results
Catalog Number C-HSK-3038
Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
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 been returned to the factory and is being evaluated. A supplemental report will be submitted when the evaluation is completed.
 
Event Description
The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 3. 8mm cutter produced a typical aortotomy but when the delivery tube was inserted into the aorta, the surgeon was not able to use the device to push the hs forward into the aorta. He was quite aggressive, breaking the white button off the delivery tube as a result. A replacement device was used to complete the procedure. Then the side-biting clamp applied when that "failed" as well.
 
Manufacturer Narrative
(b)(4). The device was returned to the factory for evaluation. Signs of clinical use and evidence of blood were observed. The delivery device was returned outside the loading device. The tension spring assembly remained in the delivery tube with the seal completely extended outside the tube. The extended seal was observed in unfolded/unwrapped state. Blood was visible on the seal. The blue slide lock was engaged and the white plunger was broken. The broken plunger was not returned back. Blood was visible in the delivery device indicating that there was attempt to deploy the device into the aorta. Based on the received condition of the device we were not able to measure the delivery tube dimensions. Based on the findings and investigation the complaint was not confirmed for the reported failure mode "failure to deploy" but was confirmed for the analyzed failure mode "break".
 
Event Description
The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 3. 8 mm cutter produced a typical aortotomy but when the delivery tube was inserted into the aorta, the surgeon was not able to use the device to push the hs forward into the aorta. He was quite aggressive, breaking the white button off the delivery tube as a result. A replacement device was used to complete the procedure. Then the side-biting clamp applied when that "failed" as well.
 
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Brand NameHS III PROXIMAL SEAL SYTEM 3.8MM
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 Key6397599
MDR Text Key69737901
Report Number2242352-2017-00243
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K080169
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/04/2017
Device Catalogue NumberC-HSK-3038
Device Lot Number25124868
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/24/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/29/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/03/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/10/2017 Patient Sequence Number: 1
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