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U.S. Department of Health and Human Services

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

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MAQUET CV HS III PROXIMAL SEAL CLAMP, VASCULAR Back to Search Results
Catalog Number C-HS-3045
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Failure to Anastomose (1028)
Event Date 03/10/2017
Event Type  malfunction  
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 was deployed properly; however, it was not covering the hole opened by the (b)(4). The customer tried for 3 times and failed all with the same results. The customer finally succeeded in the fourth time. It doesn¿t look like the event occurred due to the defect of the device; the anastomotic opening might have been torn a bit, therefore the seal didn¿t stay at the opening. A replacement device was used to complete the procedure. The hospital did not report any patient effects. Related to (b)(4). There are a total of 3 complaints.
 
Manufacturer Narrative
(b)(4). The reported device aortic cutter and the loading device were not returned to the factory for investigation. The delivery device was returned to the factory for investigation. Signs of clinical usage and evidence of blood were observed. Blood was observed in the casing of the delivery device. Blood was observed on the blue slide lock and plunger. The blue slide lock was dis-engaged and the white plunger was fully depressed on the delivery device. The tension spring assembly remained in the delivery tube with the seal extended outside the tube in an unfolded/unwrapped state. Specs of blood was visible on the delivery device indicating that there was attempt to deploy the device into the aorta. The seal was removed from the delivery tube and was observed to be intact with no cracks or delamination. The following measurements were taken; the inner delivery tube diameter was measured at. 197 in. The outer diameter was measured at. 221 in. The length of the delivery tube was measured at 2. 52 in. The values recorded were within the tolerance specifications. Based on the returned condition of the device the reported failure mode "leak" could not be confirmed.
 
Event Description
The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal was deployed properly; however, it was not covering the hole opened by the ac-3038. The customer tried for 3 times and failed all with the same results. The customer finally succeeded in the fourth time. It doesn¿t look like the event occurred due to the defect of the device; the anastomotic opening might have been torn a bit, therefore the seal didn¿t stay at the opening. A replacement device was used to complete the procedure. The hospital did not report any patient effects. Related to (b)(4). There are a total of 3 complaints.
 
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Brand NameHS III PROXIMAL SEAL
Type of DeviceCLAMP, VASCULAR
Manufacturer (Section D)
MAQUET CV
45 barbour pond drive
wayne NJ 07470
MDR Report Key6484568
MDR Text Key72786955
Report Number2242352-2017-00354
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K080169
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/11/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/12/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/22/2017
Device Catalogue NumberC-HS-3045
Device Lot Number25128199
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/05/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/25/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/22/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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