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

Model Number	24700
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified iliac artery.A 6.0mm x 20mm x 80cm (4f) sterling balloon catheter was advanced for dilation.However, on the second inflation, the balloon ruptured.The device was removed without any problem and the procedure was completed with another of same device.There were no patient complications nor injuries reported.The patient was in good condition post procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a sterling balloon with the batch number of 26550325 located on the device hub.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination did not reveal any damage, but microscopic examination revealed a small pinhole tear at 34mm from the tip.Inspection of the remainder of the device showed no signs of additional damage to the device.Product analysis confirmed the presence of a material rupture.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified iliac artery.A 6.0mmx20mmx80cm (4f) sterling balloon catheter was advanced for dilation.However, on the second inflation, the balloon ruptured.The device was removed without any problem and the procedure was completed with another of same device.There were no patient complications nor injuries reported.The patient was in good condition post procedure.

• 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: 12930433
• Report Number: 2134265-2021-15359
• Device Sequence Number: 4827998
• Product Code: DQY
• UDI-Device Identifier: 08714729123750
• UDI-Public: 08714729123750
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K053116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2021

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: 05/06/2023
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0025495555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2021
• Supplement Date Received by Manufacturer: 12/16/2021
• Initial Report FDA Received Date: 12/04/2021
• Supplement Report FDA Received Date: 12/31/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2020
• 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