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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 Failure (1158)
Patient Problem No Information (3190)
Event Date 07/21/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 4. 3mm seal did not deploy properly, so they removed it. Case was completed with a partial occluder clamp. The hospital did not report any patient effects.
 
Manufacturer Narrative
(b)(4). The device was returned to the factory for evaluation. Signs of clinical usage and evidence of blood were observed. The delivery device was returned outside the loading device. Blood was observed on the loading device. The tension spring assembly and seal were not returned for investigation and the position was unable to be determined. 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. The reported complaint ¿failure to deploy¿ was not confirmed.
 
Event Description
The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 4. 3mm seal did not deploy properly, so they removed it. Case was completed with a partial occluder clamp. The hospital did not report any patient effects.
 
Manufacturer Narrative
On 08/10/2017 10:18 am (gmt-4:00) added by(b)(4). Internal complaint number trackwise(b)(4). (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 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. 3mm seal did not deploy properly, so they removed it. Case was completed with a partial occluder clamp. The hospital did not report any patient effects.
 
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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
Manufacturer (Section G)
MAQUET CV
45 barbour pond drive
wayne NJ 07470
Manufacturer Contact
45 barbour pond drive
wayne, NJ 07470
MDR Report Key6792710
MDR Text Key109420084
Report Number2242352-2017-00772
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 Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 08/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/14/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/07/2018
Device Catalogue NumberC-HSK-3043
Device Lot Number25131800
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/11/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received08/25/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/07/2017
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: 08/14/2017 Patient Sequence Number: 1
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