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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Calcium Deposits/Calcification (1758)
Event Date 11/25/2016
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, an off pump cab, heartstring iii 4.3 proximal anastomotic device was desired by the surgeon.After palpating the ascending aorta, a soft spot was identified and periaortic tissue was dissected from site in the usual fashion in preparation for proximal anastomosis.The 4.3 aortic punch was deployed without any complications.The 4.3 heartstring was then inserted into aortotomy without complication.Once deployed in the aorta, the delivery device was gently removed.The tension device and the removal portion of the device was visible on the outside of the aorta but the device was not providing adequate hemostasis.Gentle manual repositioning of the device was performed without any success.This device was removed and an additional 4.3 hsk was deployed in the aorta with the same results.A partial occlusion aortic clamp was then placed on the aorta revealing a large shelf of calcium extending around aortotomy site.Hospital believes this is not a product failure as much as it is just a bad aorta.(1st device used in case) related to (b)(4).
 
Manufacturer Narrative
(b)(4).The device was returned to the factory for evaluation.Signs of clinical use and evidence of blood were observed.Loading device was not returned for investigation.Delivery device was returned back with the proximal seal missing tether and tension spring.The seal was observed crack and delaminated on the outer side of the coil.Blood was visible on the seal.The blue slide lock was dis-engaged and the white plunger was fully depressed on the delivery device.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 upon the received condition of the device, both the reported failure "leak seal" and analyzed failure "crack seal" was confirmed.
 
Event Description
The hospital reported that during a coronary artery bypass procedure, an off pump cab, heartstring iii 4.3 proximal anastomotic device was desired by the surgeon.After palpating the ascending aorta, a soft spot was identified and periaortic tissue was dissected from site in the usual fashion in preparation for proximal anastomosis.The 4.3 aortic punch was deployed without any complications.The 4.3 heartstring was then inserted into aortotomy without complication.Once deployed in the aorta, the delivery device was gently removed.The tension device and the removal portion of the device was visible on the outside of the aorta but the device was not providing adequate hemostasis.Gentle manual repositioning of the device was performed without any success.This device was removed and an additional 4.3 hsk was deployed in the aorta with the same results.A partial occlusion aortic clamp was then placed on the aorta revealing a large shelf of calcium extending around aortotomy site.Hospital believes this is not a product failure as much as it is just a bad aorta.(1st device used in case) related to (b)(4).
 
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Brand Name
HS III PROXIMAL SEAL SYTEM 4.3MM
Type of Device
CLAMP, 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 Key6189008
MDR Text Key62839318
Report Number2242352-2016-01300
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 Nurse
Type of Report Initial,Followup
Report Date 11/25/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date10/17/2017
Device Catalogue NumberC-HSK-3043
Device Lot Number25128881
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/07/2016
Is the Reporter a Health Professional? Yes
Device AgeYR
Initial Date Manufacturer Received 11/25/2016
Initial Date FDA Received12/20/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/26/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/17/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age71 YR
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