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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 Component Falling (1105)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/08/2018
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 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 preparation for a coronary artery bypass procedure, hs proximal seal system customer tried to set the device according to the procedure, however, the seal dropped in the loader when the delivery system was pulled out and was unable to use. A replacement device was used to complete the procedure. The hospital did not report any patient effects.
 
Manufacturer Narrative
(b)(4). The device was returned to the factory for evaluation. The loading device was not returned for evaluation. The delivery device was returned for evaluation. A visual inspection was conducted. Signs of clinical use and evidence of blood were observed on the outermost coil of the ring. The blue slide lock was disengaged and the white plunger on the delivery device was fully depressed. The seal and tension spring were observed in the delivery tube with the seal extended outside the delivery tube. The seal and tension spring were removed from the delivery tube. There were no cracks or delamination observed on the seal. There were no visual defects observed. The following measurements of the delivery tube were taken: the inner delivery tube diameter was measured at. 198 inches, the outer diameter was measured at. 220 inches. The length of the delivery tube was measured at 2. 50 inches. The values recorded were within the tolerance specifications. Based upon the received condition of the device, the reported failure "fitting problem" is not confirmed.
 
Event Description
The hospital reported that during preparation for a coronary artery bypass procedure, hs proximal seal system customer tried to set the device according to the procedure, however, the seal dropped in the loader when the delivery system was pulled out and was unable to use. A replacement device was used to complete the procedure. The hospital did not report any patient effects.
 
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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 Key7556255
MDR Text Key109793137
Report Number2242352-2018-00508
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
PMA/PMN Number
K080169
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 05/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/31/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/18/2019
Device Catalogue NumberC-HS-3045
Device Lot Number25136580
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/05/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/05/2018
Is This a Reprocessed and Reused Single-Use Device? No

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