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	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the heavily calcified anterior tibial artery of the left leg.A 3.0mm x 100mm x 150cm sterling sl balloon catheter was advanced for dilation.However, during inflation, the balloon ruptured.The device was removed and the procedure was completed with a charger balloon of the same size.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a sterling otw balloon catheter.The balloon was loosely folded and bloody.Analysis of the tip, balloon, and inner/outer shaft included microscopic and visual inspection.Inspection revealed a hole in the balloon material located 11mm from the tip.Inspection of the rest of the device found no other damage or defects.The reported balloon rupture was confirmed.Review of the product specification indicates the rated burst pressure (rbp) of the complaint device is 14atm.The reported information indicates the device was inflated to 10atm; therefore, there is no indication the device was inflated over rbp.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the heavily calcified anterior tibial artery of the left leg.A 3.0mm x 100mm x 150cm sterling sl balloon catheter was advanced for dilation.However, during inflation, the balloon ruptured.The device was removed and the procedure was completed with a charger balloon of the same size.There were no patient complications reported.It was further reported that he balloon ruptured during initial inflation at 10 atmospheres.
Additional Manufacturer Narrative
B5 - describe event or problem updated.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the heavily calcified anterior tibial artery of the left leg.A 3.0mm x 100mm x 150cm sterling sl balloon catheter was advanced for dilation.However, during inflation, the balloon ruptured.The device was removed and the procedure was completed with a charger balloon of the same size.There were no patient complications reported.It was further reported that the balloon ruptured during initial inflation at 10 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: 11032989
• Report Number: 2134265-2020-18046
• Device Sequence Number: 16405850
• Product Code: DQY
• UDI-Device Identifier: 08714729782292
• UDI-Public: 08714729782292
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/01/2021

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: 10/26/2022
• Device Model Number: 24702
• Device Catalogue Number: 24702
• Device Lot Number: 0026246427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Initial Date Received by Manufacturer: 12/11/2020
• Supplement Date Received by Manufacturer: 12/16/2020; 01/26/2021
• Initial Report FDA Received Date: 12/17/2020
• Supplement Report FDA Received Date: 01/05/2021; 02/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR