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

Model Number	24703
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event is unknown e1: initial reporter email: (b)(6).
Event or Problem Description
It was reported that the balloon was difficult to deflate and difficult to remove.This 2.5mm x 120mm x 90cm sterling sl balloon catheter was selected for use in a percutaneous transluminal angioplasty procedure.After use, the balloon would not deflate immediately, and it was complicated to remove it.There was no harm to the patient.
Event or Problem Description
It was reported that the balloon was difficult to deflate and difficult to remove.This 2.5mm x 120mm x 90cm sterling sl balloon catheter was selected for use in a percutaneous transluminal angioplasty procedure.After use, the balloon would not deflate immediately, and it was complicated to remove it.There was no harm to the patient.It was further reported that the balloon was being used for pre-dilation in a lower extremity thrombectomy.The balloon was able to be fully removed from the patient after it was deflated with difficulty.
Additional Manufacturer Narrative
Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, this sterling sl balloon catheter was returned stuck on an unknown introducer sheath.The outer shaft, inner shaft, balloon, and tip were visually and microscopically examined.Visual examination revealed that the inflation lumen was stretched 10cm from the hub.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found damage that would have contributed to the deflation issue.
Event or Problem Description
It was reported that the balloon was difficult to deflate and difficult to remove.This 2.5mm x 120mm x 90cm sterling sl balloon catheter was selected for use in a percutaneous transluminal angioplasty procedure.After use, the balloon would not deflate immediately, and it was complicated to remove it.There was no harm to the patient.It was further reported that the balloon was being used for pre-dilation in a lower extremity thrombectomy.The balloon was able to be fully removed from the patient after it was deflated with difficulty.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18588537
• Report Number: 2124215-2024-02926
• Device Sequence Number: 17932017
• Product Code: DQY
• UDI-Device Identifier: 08714729782445
• UDI-Public: 08714729782445
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/11/2024

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: 06/04/2025
• Device Model Number: 24703
• Device Catalogue Number: 24703
• Device Lot Number: 0031751096
• 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: 01/15/2024
• Supplement Date Received by Manufacturer: 02/13/2024; 03/07/2024
• Initial Report FDA Received Date: 01/26/2024
• Supplement Report FDA Received Date: 02/27/2024; 03/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2023
• 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