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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ISLEEVE 15F INTRODUCER, CATHETER

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BOSTON SCIENTIFIC CORPORATION ISLEEVE 15F INTRODUCER, CATHETER Back to Search Results
Model Number 10445
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Thrombosis (2100)
Event Date 10/29/2020
Event Type  Injury  
Event Description
It was reported that thrombosis occurred. The patient anatomy consisted of small peripheral arteries. A 15f isleeve introducer sheath was inserted into the left femoral artery with no issue. A 23mm lotus edge valve was successfully implanted. Post valve implant, the patient developed lbbb. A temporary pacemaker remained in the patient following completion of the procedure. One day post procedure, during a follow-up echocardiogram, the patient was observed to have an episode of symptomatic chb. The chb resolved on its own and electrophysiology was consulted. In addition, the patient's left foot was observed to be pulseless. The loss of a pulse was suspected to be caused by a clot following the implant procedure. A heparin drip was initiated and the event resolved. At the time of reporting, the patient was still hospitalized.
 
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Brand NameISLEEVE 15F
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key10879684
MDR Text Key217661190
Report Number2134265-2020-15787
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 11/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/03/2022
Device Model Number10445
Device Catalogue Number10445
Device Lot Number0025800690
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/29/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/03/2020
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: 11/20/2020 Patient Sequence Number: 1
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