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

Model Number	24690
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that contamination occurred.The 99% stenosed target lesion was located in the mildly tortuous and moderately calcified right superficial femoral artery.A 4.0mmx40mmx135cm (4f) sterling balloon catheter was selected for use.During the procedure, it was noted that a hair was found in the product.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
B5.Describe event or problem: updated per the additional information provided.The device was returned for analysis and the evaluation was completed.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed a strand of hair.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported complaint.
Event or Problem Description
It was reported that contamination occurred.The 99% stenosed target lesion was located in the mildly tortuous and moderately calcified right superficial femoral artery.A 4.0mmx40mmx135cm (4f) sterling balloon catheter was selected for use.During the procedure, it was noted that a hair was found in the product package.The procedure was completed with another of the same device.No patient complications were reported.It was further reported that there was no issue noted with the seal of the pouch and no damage to the packaging.The pouch was opened during preparation and the hair was found after the package was opened.

• 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: 20429039
• Report Number: 2124215-2024-63695
• Device Sequence Number: 12659836
• Product Code: DQY
• UDI-Device Identifier: 08714729756996
• UDI-Public: 08714729756996
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 11/19/2024

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: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0033858131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 10/11/2024
• Supplement Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2024
• 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