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

Model Number	24715
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used the first date of the month of the aware date as no event date was provided.
Event or Problem Description
It was reported that balloon rupture occurred.A 5.0x150x150-hybrid sterling balloon catheter was advanced for dilation; however, during inflation at 12 atmospheres, the balloon ruptured.No known patient complications were reported.
Additional Manufacturer Narrative
B3 date of event updated.B5 describe event or problem updated.E1 initial reporter title updated.E1 initial reporter last name updated.
Event or Problem Description
It was reported that balloon rupture occurred.A 5.0x150x150-hybrid sterling balloon catheter was advanced for dilation; however, during inflation at 12 atmospheres, the balloon ruptured.No known patient complciations were reported.It was further reported that the 60% stenosed target lesion was located in the moderately calcified and non-tortuous popliteal artery.Previously, it was reported that the balloon ruptured at 12 atmospheres.Now, it is reported that it ruptured at 13 atmospheres.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed a longitudinal tear in the balloon 38mm from the tip and is approximately 48mm long.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that balloon rupture occurred.A 5.0x150x150-hybrid sterling balloon catheter was advanced for dilation; however, during inflation at 12 atmospheres, the balloon ruptured.No known patient complciations were reported.It was further reported that the 60% stenosed target lesion was located in the moderately calcified and non-tortuous popliteal artery.Previously, it was reported that the balloon ruptured at 12 atmospheres.Now, it is reported that it ruptured at 13 atmospheres.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11433608
• Report Number: 2134265-2021-02924
• Device Sequence Number: 19713595
• Product Code: LIT
• UDI-Device Identifier: 08714729845362
• UDI-Public: 08714729845362
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/14/2021

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: 03/23/2022
• Device Model Number: 24715
• Device Catalogue Number: 24715
• Device Lot Number: 0026069993
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2021
• Initial Date Received by Manufacturer: 02/25/2021
• Supplement Date Received by Manufacturer: 03/11/2021; 04/01/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 03/22/2021; 04/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1