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

Model Number	24703
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2023: it was reported, that balloon leak was encountered.The 80% stenosed target lesion was located in the superficial femoral artery and infrapopliteal.A 3.0mm x 150mm x 150cm fg sterling balloon catheter was prepared by flushing.However, during preparation, it was observed that the balloon was leaking gas.The procedure was completed with another of same device.There were no patient complications nor injuries reported.And the patient status was stable.However, returned device analysis revealed a longitudinal torn.
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).E1.Initial reporter phone: (b)(6).Device evaluated by mfr.: returned product consisted of a sterling sl balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed a longitudinal tear 13mm from the tip and is approximately 6mm long.There is contrast inside the balloon, and the balloon is loose.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed, there is a longitudinal tear in the balloon.

• Brand Name: STERLING SL
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 17182056
• Report Number: 2124215-2023-31870
• Device Sequence Number: 6495871
• Product Code: DQY
• UDI-Device Identifier: 08714729782315
• UDI-Public: 08714729782315
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 06/22/2023

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: 05/25/2024
• Device Model Number: 24703
• Device Catalogue Number: 24703
• Device Lot Number: 0029480889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2023
• Initial Report FDA Received Date: 06/22/2023
• Date Device Manufactured: 05/26/2022
• 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 Age: 58 YR
• Patient Sex: Male
• Patient Weight: 75 KG