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

Model Number	24703
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that balloon rupture occurred.A 3.5mm x 120mm x 150cm sterling sl balloon catheter was advanced for dilation.However, on the second inflation before reaching the rated burst pressure, the balloon burst.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.
Additional Manufacturer Narrative
(a2) age at time of event: 18 years or older.
Event or Problem Description
It was reported that balloon rupture occurred.A 3.5mm x 120mm x 150cm sterling sl balloon catheter was advanced for dilation.However, on the second inflation before reaching the rated burst pressure, the balloon burst.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.It was further reported that the target lesion had 50% stenosis which was located in the anterioir tibial artery.

• 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: 10257939
• Report Number: 2134265-2020-09107
• Device Sequence Number: 3485208
• Product Code: DQY
• UDI-Device Identifier: 08714729782346
• UDI-Public: 08714729782346
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K093720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2020

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: 03/26/2020
• Device Model Number: 24703
• Device Catalogue Number: 24703
• Device Lot Number: 0021919042
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/03/2020
• Supplement Date Received by Manufacturer: 07/12/2020
• Initial Report FDA Received Date: 07/10/2020
• Supplement Report FDA Received Date: 07/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1