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

Model Number	H74939148301510
Medical Device Problem Codes	Material Rupture (1546); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 60% stenosed target lesion was located in the moderately tortuous and moderately calcified lower patellar artery of lower limb.A 3.0mm x 150mm x 150cm sterling sl balloon catheter was advanced for pre-dilatation and was inflated to 6 atmospheres.The device was removed through sheath.After removal, it was found that the balloon had burst, and the catheter was twisted.The procedure was completed with another of same device.There were no complications were reported and the patient status was stable post procedure.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6).Device evaluated by mfr: the device was returned for evaluation.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed buckling to the guidewire lumen 14cm from the tip.Microscopic examination revealed no additional damage.The device was inflated to rated burst pressure and it was able to hold pressure.Inspection of the remainder of the device presented no other damage or irregularities.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The 60% stenosed target lesion was located in the moderately tortuous and moderately calcified lower patellar artery of lower limb.A 3.0mm x 150mm x 150cm sterling sl balloon catheter was advanced for pre-dilatation and was inflated to 6 atmospheres.The device was removed through sheath.After removal, it was found that the balloon had burst, and the catheter was twisted.The procedure was completed with another of same device.There were no complications were reported and the patient status was stable post procedure.
Event or Problem Description
It was reported that balloon rupture occurred.The 60% stenosed target lesion was located in the moderately tortuous and moderately calcified lower patellar artery of lower limb.A 3.0mm x 150mm x 150cm sterling sl balloon catheter was advanced for pre-dilatation and was inflated to 6 atmospheres.The device was removed through sheath.After removal, it was found that the balloon had burst, and the catheter was twisted.The procedure was completed with another of same device.There were no complications were reported and the patient status was stable post procedure.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6) hospital.Device evaluated by mfr: the device was returned for evaluation.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed buckling to the guidewire lumen 14cm from the tip.Microscopic examination revealed no additional damage.The device was inflated to rated burst pressure and it was able to hold pressure.Inspection of the remainder of the device presented no other damage or irregularities.No other issues were identified during the product analysis.This report is being filed to correct the model number and unique identifier (udi) # in response to an fda request.

• 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: 18119284
• Report Number: 2124215-2023-63512
• Device Sequence Number: 7503000
• Product Code: DQY
• UDI-Device Identifier: 08714729782315
• UDI-Public: (01)08714729782315(17)240308(10)29010317
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/03/2024

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: 03/08/2024
• Device Model Number: H74939148301510
• Device Catalogue Number: 24703
• Device Lot Number: 0029010317
• 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: 11/06/2023
• Supplement Date Received by Manufacturer: 01/12/2024; 06/12/2024
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 01/31/2024; 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2022
• 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: 52 YR
• Patient Sex: Male
• Patient Weight: 75 KG