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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE VESSIX VESSIX¿ GUIDE SHEATH

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BOSTON SCIENTIFIC - MAPLE GROVE VESSIX VESSIX¿ GUIDE SHEATH Back to Search Results
Model Number H749RDNDCL14500
Device Problem Material Too Rigid or Stiff (1544)
Patient Problem Blood Loss (2597)
Event Date 07/13/2017
Event Type  Injury  
Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a vessix guide sheath. The hemostatic valve, hub, tip and shaft were visually and microscopically examined. There was blood in the device, hub and the valve. There were numerous kinks throughout the shaft. A syringe filled with water was hooked up to the adapter unit and flushed. There were no leaks or irregularities. Because there was no evidence of any product quality deficiencies, it was considered likely that the kinks were attributable to handling of the device. Inspection of the remainder of the device presented no other damage or irregularities. Device analysis determined the condition of the returned device was not consistent with the reported information. Product analysis did not confirm the reported leak and the reported stiffness was a preference of the user. Reviews of documentation to ensure that all required in-process and final inspections and testing were completed and all acceptance criteria were met. There is no evidence that the device failed to meet applicable product specifications prior to shipment. The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty. (b)(4).
 
Event Description
Reinforce clinical study. It was reported that the patient experienced bleeding. A 7f, 45cm, vessix guide sheath was inserted into the right femoral artery to assist in a renal artery denervation procedure. The sheath was stiff and hard to work with and there was "extensive" bleeding and leakage through the sheath. This resulted in extra time to complete the procedure. The procedure was completed with this device, there were no further patient complications reported and the patient was discharged from the hospital later that day.
 
Manufacturer Narrative
(b)(4). Device evaluated by mfr. : it is indicated that the device will not be returned for evaluation. A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted. If there is any further relevant information from that review, a supplemental medwatch will be filed. (b)(4).
 
Event Description
(b)(6) study. It was reported that the patient experienced bleeding. A 7f, 45cm, vessix¿ guide sheath was inserted into the right femoral artery to assist in a renal artery denervation procedure. The sheath was stiff and hard to work with and there was "extensive" bleeding and leakage through the sheath. This resulted in extra time to complete the procedure. The procedure was completed with this device, there were no further patient complications reported and the patient was discharged from the hospital later that day.
 
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Brand NameVESSIX
Type of DeviceVESSIX¿ GUIDE SHEATH
Manufacturer (Section D)
BOSTON SCIENTIFIC - MAPLE GROVE
one scimed place
maple grove MN 55311
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key6785571
MDR Text Key246287128
Report Number2134265-2017-07758
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2017
Device Model NumberH749RDNDCL14500
Device Catalogue NumberRDNDCL1450
Device Lot Number17410053
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/08/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/10/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/13/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/10/2017 Patient Sequence Number: 1
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