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	03/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 50% stenosed target lesion was located in the non-tortuous and moderately calcified distal of superficial femoral artery.A 6.0mmx100mmx135cm-hybrid sterling balloon catheter was advanced for post dilation.However, on initial inflation at 8 atmospheres for 10 seconds, the balloon ruptured.The device was completely removed and the procedure was completed with another of the same device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a sterling balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed, a longitudinal tear 7.3cm from the tip and it is approximately 3.7cm long.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported, that balloon rupture occurred.The 50% stenosed, target lesion was located in the non-tortuous.And moderately calcified distal of superficial femoral artery.A 6.0mmx100mmx135cm, hybrid sterling balloon catheter was advanced for post dilation.However, on initial inflation at 8 atmospheres for 10 seconds, the balloon ruptured.The device was completely removed.And the procedure was completed with another of the same device.There were no patient complications nor injuries reported.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11552581
• Report Number: 2134265-2021-03720
• Device Sequence Number: 11719974
• Product Code: DQY
• UDI-Device Identifier: 08714729123682
• UDI-Public: 08714729123682
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2021

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: 07/20/2023
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0025738418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2021
• Initial Date Received by Manufacturer: 03/15/2021
• Supplement Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 03/23/2021
• Supplement Report FDA Received Date: 05/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR