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

Model Number	24716
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.A 3.0x220x150 (4f) sterling balloon catheter was advanced for dilation.However, during inflation at 4 atmospheres, the balloon ruptured.The device was removed and the procedure was completed with another of same device.No patient complications were reported.
Event or Problem Description
It was reported that balloon rupture occurred.A 3.0x220x150 (4f) sterling balloon catheter was advanced for dilation.However, during inflation at 4 atmospheres, the balloon ruptured.The device was removed and the procedure was completed with another of same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the returned product consisted of a sterling otw balloon catheter.The balloon was loosely folded, and the device was filled with blood.The device was soaked in a warm water bath for 5 days.Analysis of the tip, balloon, and inner/outer shaft included microscopic and visual inspection.Inspection revealed a burst in the balloon material that was 20mm in length.Inspection of the rest of the device found no other damage or defect.There is no indication the device was inflated over rated burst pressure (rbp).

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11019384
• Report Number: 2134265-2020-17777
• Device Sequence Number: 14408831
• Product Code: LIT
• UDI-Device Identifier: 08714729860174
• UDI-Public: 08714729860174
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2021

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: 12/22/2021
• Device Model Number: 24716
• Device Catalogue Number: 24716
• Device Lot Number: 0025639951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Initial Date Received by Manufacturer: 12/07/2020
• Supplement Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 02/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR