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

Model Number	24716
Medical Device Problem Codes	Material Rupture (1546); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the superficial femoral artery.A 6.0x220x150-hybrid sterling balloon catheter was selected for use.However, upon opening the package, it was noticed that the balloon was wrapped strangely and twisted on delivery shaft.The balloon was initially inflated but did not inflate properly with a significant waist at the mid point of the balloon.After deflation and re-inflation of the balloon, the wrap/waist resolved.The procedure was completed with a different device.There were no patient complications nor injuries reported.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the superficial femoral artery.A 6.0x220x150-hybrid sterling balloon catheter was selected for use.However, upon opening the package, it was noticed that the balloon was wrapped strangely and twisted on delivery shaft.The balloon was initially inflated but did not inflate properly with a significant waist at the mid point of the balloon.After deflation and re-inflation of the balloon, the wrap/waist resolved.The procedure was completed with a different device.There were no patient complications nor injuries reported.It was further reported that the target lesion was 90% stenosed, non-tortuous and mildly calcified.Additionally, no pinhole was noted on the balloon material.The balloon was successfully inflated on the third attempt and the procedure was completed with the device.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• 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 Key: 14025150
• Report Number: 2134265-2022-04061
• Device Sequence Number: 16793251
• Product Code: LIT
• UDI-Device Identifier: 08714729845485
• UDI-Public: 08714729845485
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K132430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/06/2025
• Device Model Number: 24716
• Device Catalogue Number: 24716
• Device Lot Number: 0028641002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2022
• Supplement Date Received by Manufacturer: 04/24/2022
• Initial Report FDA Received Date: 04/06/2022
• Supplement Report FDA Received Date: 05/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown