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

Model Number 1177-01

Device Problems Failure to Advance (2524); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/18/2022

Event Type  Injury  

Event Description

It was reported that during removal this balloon became dislodged and detached due to calcification leaving unretrieved fragments in the patient.This ranger drug-coated balloon 8.0 mm x 40 mm, 80 cm was initially reported as a no cross.Additional information was received that during the this treatment.The balloon was deflated and withdrawn without resistance, but it got dislodged (distal part severed) and detached from the guide due to the presence of calcification.Upon withdrawal, the balloon remained inside the stent and got separated from the guide when exiting the later.The surgeon attempted to get it back, but it was impossible; therefore, an additional stent was deployed to block the unrecoverable balloon between the 2 stents.No patient complications were reported.

• Brand Name: RANGER
• Type of Device: CATHETER, 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15122607
• MDR Text Key: 296786455
• Report Number: 2134265-2022-07586
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): Y
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2023
• Device Model Number: 1177-01
• Device Catalogue Number: 1177-01
• Device Lot Number: 07996H21
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention