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

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.

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 dislodged clot was removed and the procedure was completed.No further patient complications were reported in relation to this event.It was further reported that part of the ranger balloon migrated to the patient lung.A procedure was performed to remove the piece of the ranger baloon.No additional patient complications were reported in relation to this event.

• Brand Name: RANGER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9985428
• MDR Text Key: 188485520
• Report Number: 2134265-2020-05448
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• 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 Received: 04/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/02/2020
• Device Model Number: 26102
• Device Catalogue Number: 26102
• Device Lot Number: 7534H18
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention