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

Model Number	24703
Medical Device Problem Codes	Material Rupture (1546); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture and marker band issue occurred.The patient underwent popliteal artery stent placement.The 90% stenosed target lesion was located in the severely tortuous and non-calcified popliteal artery in the right lower limb.A 2.0mm x 150mm x 150cm sterling sl balloon catheter was advanced for dilation.However, during balloon introduction, three markers were found under fluoroscopy, and it was then confirmed that the balloon burst during withdrawal.The device was removed completely, and the procedure was completed with another of same device.No patient complications were reported, and patient status was stable.
Additional Manufacturer Narrative
Initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that balloon rupture and marker band issue occurred.The patient underwent popliteal artery stent placement.The 90% stenosed target lesion was located in the severely tortuous and non-calcified popliteal artery in the right lower limb.A 2.0mm x 150mm x 150cm sterling sl balloon catheter was advanced for dilation.However, during balloon introduction, three markers were found under fluoroscopy, and it was then confirmed that the balloon burst during withdrawal.The device was removed completely, and the procedure was completed with another of same device.No patient complications were reported, and patient status was stable.
Additional Manufacturer Narrative
E1: initial reporter address 1: (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 a longitudinal tear to the balloon and guidewire lumen 1mm from the tip and is approximately 9mm long.Microscopic examination revealed that the markerband is cut in half the longitudinally.Half of the marker band is missing.The marker band is no longer in the manufactured position and is able to shift freely inside the balloon.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed that the balloon is torn longitudinally and the markerband is damaged.

• 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: 16709430
• Report Number: 2124215-2023-15011
• Device Sequence Number: 14935176
• Product Code: DQY
• UDI-Device Identifier: 08714729782230
• UDI-Public: 08714729782230
• 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,Followup
• Report Date (Section B): 06/07/2023

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: 09/14/2024
• Device Model Number: 24703
• Device Catalogue Number: 24703
• Device Lot Number: 0030152799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2023
• Supplement Date Received by Manufacturer: 05/11/2023
• Initial Report FDA Received Date: 04/10/2023
• Supplement Report FDA Received Date: 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2022
• 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: 74 YR
• Patient Sex: Female
• Patient Weight: 69 KG