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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 Problems Material Rupture (1546); Detachment of Device or Device Component (2907)
Patient Problems Pulmonary Embolism (1498); Unspecified Infection (1930); Sepsis (2067); Device Embedded In Tissue or Plaque (3165)
Event Date 11/21/2019
Event Type  Injury  
Event Description

It was reported that a balloon rupture, sepsis, and infection occurred. The target fistula was autologous with no stent and was predilated with a 7mm plain balloon. It was noted that the plain balloon did not burst. Following predilation, a 8. 0mm x 40mm, 80cm ranger balloon was inflated at the site, but a balloon burst occurred. The balloon was removed from the patient and was not inspected. The procedure was completed without patient complications. In (b)(6) 2020, the patients fistula became infected and was rushed to surgery due to sepsis. It was identified that a part of the ranger balloon and outer shaft (totaling 60mm) had been left in the patient. It was noted that the balloon was likely left in the usable segment of the fistula and had become infected following dialysis. The patient underwent surgery where the dislodged clot was removed. The procedure was completed and no further patient complications were reported in relation to this event.

 
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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 Key9985428
MDR Text Key188485520
Report Number2134265-2020-05448
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeAS
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 05/22/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/22/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/02/2020
Device MODEL Number26102
Device Catalogue Number26102
Device LOT Number7534H18
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 Received05/07/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/03/2018
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: 04/22/2020 Patient Sequence Number: 1
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