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

Model Number	24690
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a device fracture occurred.A 5.0mmx20mmx135cm (4f) sterling was selected for angioplasty of renal artery stenosis.During the course of the procedure, a 6f sheath was placed, then a v18 guidewire along with c2 imaging catheter was placed in the upper part of the aorta abdominalis.Angiography showed stenosis in the ostial of right renal artery.The c2 imaging catheter along with the v18 guidewire was placed in the right renal artery.Then, the pta balloon was prepared for pre-dilation, but after unpacking, it was noted that the delivery shaft was fractured.Another 6-20mm balloon was used for pre-dilation.A 6-18mm pre-loaded stent system was placed, and afterwards an angiography showed that the blood vessel was in good condition with smooth blood flow and no leakage of contrast.The procedure was completed successfully.No complications were reported and the patient was stable post-procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: the complaint device was received for product analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the shaft is separated 28.8cm from the tip.The shaft appears to be stretched prior to separating.There are multiple kinks along the shaft.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that a device fracture occurred.A 5.0mmx20mmx135cm (4f) sterling was selected for angioplasty of renal artery stenosis.During the course of the procedure, a 6f sheath was placed, then a v18 guidewire along with c2 imaging catheter was placed in the upper part of the aorta abdominalis.Angiography showed stenosis in the ostial of right renal artery.The c2 imaging catheter along with the v18 guidewire was placed in the right renal artery.Then, the pta balloon was prepared for pre-dilation, but after unpacking, it was noted that the delivery shaft was fractured.Another 6-20mm balloon was used for pre-dilation.A 6-18mm pre-loaded stent system was placed, and afterwards an angiography showed that the blood vessel was in good condition with smooth blood flow and no leakage of contrast.The procedure was completed successfully.No complications were reported and the patient was stable post-procedure.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19321629
• Report Number: 2124215-2024-27827
• Device Sequence Number: 12351911
• Product Code: DQY
• UDI-Device Identifier: 08714729756194
• UDI-Public: 08714729756194
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2024

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: 07/10/2026
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0031991645
• 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: 04/26/2024
• Supplement Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2023
• 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 Age: 74 YR
• Patient Sex: Female
• Patient Weight: 60 KG