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

Model Number	24703
Medical Device Problem Codes	Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the superficial femoral artery.A 2.0mm x 120mm x 150cm sterling sl balloon catheter was advanced for dilatation.However, during inflation, the balloon burst before reaching the nominal pressure.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the superficial femoral artery.A 2.0mm x 120mm x 150cm sterling sl balloon catheter was advanced for dilatation.However, during inflation, the balloon burst before reaching the nominal pressure.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 was 80% stenosed, non-tortuous and mildly calcified.Additionally, the balloon ruptured during initial inflation at 3 atmospheres.
Additional Manufacturer Narrative
B5- describe event or problem updated.A2- age at time of event: 18 years or older.
Additional Manufacturer Narrative
A2- age at time of event: 18 years or older.Device evaluated by mfr.: the sterling sl was returned to boston scientific for analysis.The device was inspected for any damage or irregularities.The batch/lot number is a match to the complaint device.The device showed signs of use with blood through the entire shaft to the luer.A longitudinal tear in the balloon was confirmed 19 mm from the distal tip.The balloon was buckled 12.8 cm from the distal end.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the superficial femoral artery.A 2.0mm x 120mm x 150cm sterling sl balloon catheter was advanced for dilatation.However, during inflation, the balloon burst before reaching the nominal pressure.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 was 80% stenosed, non-tortuous and mildly calcified.Additionally, the balloon ruptured during initial inflation at 3 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14687860
• Report Number: 2134265-2022-06815
• Device Sequence Number: 14611391
• Product Code: DQY
• UDI-Device Identifier: 08714729782223
• UDI-Public: 08714729782223
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/29/2022

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: 07/29/2023
• Device Model Number: 24703
• Device Catalogue Number: 24703
• Device Lot Number: 0027747938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/08/2022
• Supplement Date Received by Manufacturer: 06/16/2022; 07/25/2022
• Initial Report FDA Received Date: 06/14/2022
• Supplement Report FDA Received Date: 06/22/2022; 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown