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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RANGER CATHETER, PERCUTANEOUS

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BOSTON SCIENTIFIC CORPORATION RANGER CATHETER, PERCUTANEOUS Back to Search Results
Model Number 26102
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/01/2020
Event Type  Malfunction  
Manufacturer Narrative

Date of event is unknown. Bsc became aware of the event on (b)(6) 2020. Therefore, a date of (b)(6) 2020 was entered to indicate that the event occurred on an unknown day in (b)(6) 2020.

 
Event Description

It was reported that a packaging issue occurred. During preparation, while outside the patient, and after the package to a 4. 0mm x 40mm, 80cm ranger balloon was opened, it was noticed that the internal packaging was already open. The procedure was completed with another of the same device. No patient complications were reported and the patient was reported to be stable following the procedure.

 
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Brand NameRANGER
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
HEMOTEQ AG
adenauerstrasse 15
wuerselen 52146
GM 52146
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key10078529
MDR Text Key191718344
Report Number2134265-2020-06637
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeGM
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 07/23/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/21/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number26102
Device Catalogue Number26102
Device LOT Number13417H19
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/02/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/01/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/26/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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