MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STERLING; CATHETER, PERCUTANEOUS

Model Number	24690
Medical Device Problem Codes	Break (1069); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The patient underwent right renal angiography, balloon dilation and renal artery stent implantation.A 3.0mm x 20mm x 135cm (4f) sterling balloon catheter was advanced for dilatation.However, during procedure, when the pressure was increased by the pump, the distal end of the balloon got broken instantaneously.The procedure was completed with a different 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 shaft break occurred.The patient underwent right renal angiography, balloon dilation and renal artery stent implantation.A 3.0mmx20mmx135cm (4f) sterling balloon catheter was advanced for dilation.However, during procedure, when the pressure was increased by the pump, the distal end of the balloon got broken instantaneously.The procedure was completed with a different device.No patient complications were reported and patient status was stable.It was further reported that it was the balloon of the device burst and not shaft break as previously reported.Also, the stenosed target lesion was located in the non-tortuous and non-calcified renal artery.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).B5.Describe event or problem- corrected and updated.H6.Device codes- corrected from break to material rupture.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a sterling 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 in the balloon 5mm from the tip and is approximately 20mm long.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there is a longitudinal tear in the balloon.(b)(6).B5.Describe event or problem- corrected and updated.H6.Device codes- corrected from break to material rupture.
Event or Problem Description
It was reported that shaft break occurred.The patient underwent right renal angiography, balloon dilation and renal artery stent implantation.A 3.0mmx20mmx135cm (4f) sterling balloon catheter was advanced for dilation.However, during procedure, when the pressure was increased by the pump, the distal end of the balloon got broken instantaneously.The procedure was completed with a different device.No patient complications were reported and patient status was stable.It was further reported that it was the balloon of the device burst and not shaft break as previously reported.Also, the stenosed target lesion was located in the non-tortuous and non-calcified renal artery.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• 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: 16613152
• Report Number: 2124215-2023-14008
• Device Sequence Number: 20066428
• Product Code: DQY
• UDI-Device Identifier: 08714729755586
• UDI-Public: 08714729755586
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K141150
• 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): 05/23/2023

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: 03/10/2025
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0029030233
• 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: 03/17/2023
• Supplement Date Received by Manufacturer: 03/28/2023; 05/11/2023
• Initial Report FDA Received Date: 03/24/2023
• Supplement Report FDA Received Date: 03/30/2023; 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2022
• 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: 70 YR
• Patient Sex: Female
• Patient Weight: 57 KG