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	11/25/2020
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 5.0x220x150 sterling balloon catheter was advanced for dilatation.However, during inflation at 8 atmospheres, the balloon ruptured.The device was removed from the patient's body and the procedure was completed with a different device.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Date of event: used the first date of the month of the aware date as no event date was provided.Updated the batch/lot# to 26161274.B3: updated the event date to (b)(6) 2020.Device evaluated by mfr: returned product consisted of a sterling balloon catheter and part of an introducer sheath.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed a longitudinal tear in the balloon 18.5cm from the tip and is approximately 4.2cm long.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there is a rupture in the balloon.
Event or Problem Description
It was reported that balloon rupture occurred.A 5.0x220x150 sterling balloon catheter was advanced for dilatation.However, during inflation at 8 atmospheres, the balloon ruptured.The device was removed from the patient's body and the procedure was completed with a different device.No patient complications were reported and the patient' status was fine.It was further reported that the lesion was 80% stenosed, non tortuous and mildly calcified.The balloon rupture during the first inflation.
Additional Manufacturer Narrative
(b3) date of event: used the first date of the month of the aware date as no event date was provided.Updated the batch/lot# to 26161274.B3: updated the event date to (b)(6) 2020.
Event or Problem Description
It was reported that balloon rupture occurred.A 5.0x220x150 sterling balloon catheter was advanced for dilatation.However, during inflation at 8 atmospheres, the balloon ruptured.The device was removed from the patient's body and the procedure was completed with a different device.No patient complications were reported and the patient' status was fine.It was further reported that the lesion was 80% stenosed, non tortuous and mildly calcified.The balloon rupture during the first inflation.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10978377
• Report Number: 2134265-2020-17267
• Device Sequence Number: 3186926
• Product Code: LIT
• UDI-Device Identifier: 08714729845409
• UDI-Public: 08714729845409
• 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): 02/26/2021

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: 04/07/2022
• Device Model Number: 24716
• Device Catalogue Number: 24716
• Device Lot Number: 0026161274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Initial Date Received by Manufacturer: 11/25/2020
• Supplement Date Received by Manufacturer: 01/28/2021; 02/23/2021
• Initial Report FDA Received Date: 12/09/2020
• Supplement Report FDA Received Date: 02/08/2021; 02/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1