MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STERLING SL; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	24702
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/18/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon pinhole occurred.Anterograde arterial access was performed via the femoral approach and transposition of a subocclusive lesion in the tibio-fibular trunk territory.The same with multiple, segmental and calcified stenotic lesions.After a 0.018 v18 wire was passed through the lesion, a 3.0mm x 80mm x 150cm sterling sl balloon catheter was advanced for dilation.However, during the first inflation, balloon dilation was unsuccessful, with loss of pressure being observed in a manometer syringe.Leakage, punctate, with leakage of insufflation fluid at the distal end of the balloon was observed.The balloon was replaced and the procedure was successfully completed.No patient complications nor injuries were reported and the patient's status was stable.
Event or Problem Description
It was reported that balloon pinhole occurred.Anterograde arterial access was performed via the femoral approach and transposition of a subocclusive lesion in the tibio-fibular trunk territory.The same with multiple, segmental and calcified stenotic lesions.After a 0.018 v18 wire was passed through the lesion, a 3.0mm x 80mm x 150cm sterling sl balloon catheter was advanced for dilation.However, during the first inflation, balloon dilation was unsuccessful, with loss of pressure being observed in a manometer syringe.Leakage, punctate, with leakage of insufflation fluid at the distal end of the balloon was observed.The balloon was replaced and the procedure was successfully completed.No patient complications nor injuries were reported and the patient's status was stable.It was further reported that the 80% stenosed target lesion was located in the moderately tortuous and midly calcified tibio-fibular, and that the balloon ruptured at 6 atmospheres.

• Brand Name: STERLING SL
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9786528
• Report Number: 2134265-2020-02451
• Device Sequence Number: 714502
• Product Code: DQY
• UDI-Device Identifier: 08714729782322
• UDI-Public: 08714729782322
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K093720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2020

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: 06/10/2021
• Device Model Number: 24702
• Device Catalogue Number: 24702
• Device Lot Number: 0023931784
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/17/2020
• Supplement Date Received by Manufacturer: 02/17/2020
• Initial Report FDA Received Date: 03/04/2020
• Supplement Report FDA Received Date: 03/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR