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

Model Number	24716
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the device was received for analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed a kink on the shaft at 3.5cm from the tip.Microscopic examination revealed a hole at the kink.A guidewire was advanced through the shaft with no issues.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported complaint of the kink, no issues were found when advancing a guidewire through the shaft.B3 - date of event: used the first date of the month of aware date as no information was provided.
Event or Problem Description
Reportable based on device analysis completed on 28oct2024.It was reported that advancing difficulties and shaft kink occurred.A 6.0x200x150-hybrid sterling balloon catheter was selected for use.However, during the procedure, the balloon catheter was kinked from the inside and a lot of resistance was felt when advancing over wire.No patient complications were reported.However, returned device analysis revealed a hole at the kink.

• 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: 20737841
• Report Number: 2124215-2024-72881
• Device Sequence Number: 12852743
• Product Code: LIT
• UDI-Device Identifier: 08714729845478
• UDI-Public: 08714729845478
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K132430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/20/2024

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 Model Number: 24716
• Device Catalogue Number: 24716
• Device Lot Number: 0032995117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2023
• 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