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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 Detachment of Device or Device Component (2907); Positioning Problem (3009)
Patient Problem No Information (3190)
Event Date 11/19/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). A lot history record review was completed for the reported product lot number. There were no ncmr¿s for the reported lot number. 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 3. 8mm did not completely roll in the delivery device loading tube. The hospital attempted to manually pull back the delivery device and seal came off midway from the loading device tube. The doctor then used a side-biting clamp on the aorta. The hospital did not report any patient effects.
 
Event Description
The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 3. 8mm did not completely roll in the delivery device loading tube. The hospital attempted to manually pull back the delivery device and seal came off midway from the loading device tube. The doctor then used a side-biting clamp on the aorta. The hospital did not report any patient effects.
 
Manufacturer Narrative
Internal complaint number: (b)(4). Autonumber: (b)(4). The device was returned to the factory for evaluation. A visual inspection was performed. Signs of clinical use was observed. There was no evidence of blood detected. The delivery device was returned inside of the loading device, with the tension spring and seal still inside. The seal is visible through the window of the loading device. The delivery device was removed from the loading device. The plunger on the delivery device was not pressed and the blue sliding lock was observed to be in the locked position. The seal with the tension spring assembly were pulled out from the loading device for inspection. The tension spring assembly and tether wire was not connected to the seal. The tether remained uncut. The seal was observed to be unraveled at the center. The following measurements of the delivery tube were taken: inner delivery tube diameter was measured at 0. 198 in. , the outer diameter was measured at 0. 220 in. The length of the delivery tube was measured at 2. 50 inches. The measurement values recorded for the delivery tube were within the tolerance specifications. Based on the returned condition of the device and the evaluation results, the reported failure ¿fitting problem¿ was confirmed, and the analyzed failure "unraveled seal" is confirmed.
 
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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
MDR Report Key8187595
MDR Text Key131130584
Report Number2242352-2018-01341
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
PMA/PMN Number
K130382
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 12/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/12/2019
Device Catalogue NumberC-HSK-3038
Device Lot Number25136433
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/02/2019
Was the Report Sent to FDA?
Device AgeYR
Event Location No Information
Date Manufacturer Received01/23/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/20/2018 Patient Sequence Number: 1
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