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 Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.A 2.0mm x 100mm x 150cm sterling sl balloon catheter was advanced for dilatation.However, prior to cross the lesion, the balloon ruptured.No patient complications reported.
Event or Problem Description
It was reported that balloon rupture occurred.A 2.0mm x 100mm x 150cm sterling sl balloon catheter was advanced for dilatation.However, prior to cross the lesion, the balloon ruptured.No patient complications reported.It was further reported that the balloon ruptured before reaching nominal pressure.The procedure was completed with another of same device and the patient condition was fine.
Event or Problem Description
It was reported that balloon rupture occurred.A 2.0mm x 100mm x 150cm sterling sl balloon catheter was advanced for dilatation.However, prior to cross the lesion, the balloon ruptured.No patient complications reported.It was further reported that the balloon ruptured before reaching nominal pressure.The procedure was completed with another of same device and the patient condition was fine.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a sterling sl balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was contrast and blood in the inflation lumen and balloon, and blood in the guidewire lumen.The balloon was loosely folded.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.There were pinholes at the proximal marker band.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported balloon ruptured.

• 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: 11477548
• Report Number: 2134265-2021-03286
• Device Sequence Number: 11743649
• Product Code: DQY
• UDI-Device Identifier: 08714729782216
• UDI-Public: 08714729782216
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K093720
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/29/2021

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: 12/03/2022
• Device Model Number: 24702
• Device Catalogue Number: 24702
• Device Lot Number: 0026456501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Initial Date Received by Manufacturer: 03/09/2021
• Supplement Date Received by Manufacturer: 03/16/2021; 04/15/2021
• Initial Report FDA Received Date: 03/12/2021
• Supplement Report FDA Received Date: 03/23/2021; 04/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1