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

Model Number	24716
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon burst and separated into two parts.A 3.0 x 220 x 150 sterling balloon catheter was selected for use in a balloon angioplasty procedure.While inflating the sterling balloon, there was an implosion and it became sectioned in two parts with risk of migration.No patient complications were reported.
Event or Problem Description
It was reported that the balloon burst and separated into two parts.A 3.0 x 220 x 150 sterling balloon catheter was selected for use in a balloon angioplasty procedure.While inflating the sterling balloon, there was an implosion and it became sectioned in two parts with risk of migration.No patient complications were reported.It was further reported that the balloon burst on the first inflation in the posterior tibial.The balloon was successfully removed from the patient, and both parts remained on the guide.No device fragments remained in the patient.The procedure was completed with another balloon.
Additional Manufacturer Narrative
Device eval by manufacturer: returned product consisted of a sterling balloon catheter.The outer shaft, inner shaft, balloon, and tip were visually and microscopically examined.Visual examination revealed that the balloon was separated 12.6cm from the tip.The distal end of the separated balloon was pulled over the tip.Microscopic examination revealed a longitudinal tear 46mm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there was a longitudinal tear in the balloon and the balloon was separated.
Event or Problem Description
It was reported that the balloon burst and separated into two parts.A 3.0 x 220 x 150 sterling balloon catheter was selected for use in a balloon angioplasty procedure.While inflating the sterling balloon, there was an implosion and it became sectioned in two parts with risk of migration.No patient complications were reported.It was further reported that the balloon burst on the first inflation in the posterior tibial.The balloon was successfully removed from the patient, and both parts remained on the guide.No device fragments remained in the patient.The procedure was completed with another balloon.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15513706
• Report Number: 2124215-2022-38488
• Device Sequence Number: 12004834
• Product Code: LIT
• UDI-Device Identifier: 08714729860174
• UDI-Public: 08714729860174
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K141112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/20/2023

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: 05/26/2025
• Device Model Number: 24716
• Device Catalogue Number: 24716
• Device Lot Number: 0029483428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/06/2022
• Supplement Date Received by Manufacturer: 10/17/2022; 01/04/2023
• Initial Report FDA Received Date: 09/30/2022
• Supplement Report FDA Received Date: 11/10/2022; 01/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown