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

Model Number	24715
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that labeling issue occurred.A 6.0mmx80mmx135cm-hybrid sterling was selected for use.However, during preparation, it was noted that the product inner pouch did not match the outer shelf carton.The procedure was completed using an alternate device.No patient complications were reported.
Additional Manufacturer Narrative
D4 lot number from 0033275889 to 0031620134.Device evaluated by mfr: the complaint device was received for product analysis.Visual examination revealed that the seal on the packaging is still intact and the batch number on the label is 31620134.Media was provided in the form of two photos.One of the photos shows the device still in the pouch with the batch number 31620134.The second photo shows a shelf box with the batch number 33275889.Inspection of the remainder of the device presented no damage or irregularities.Media analysis confirmed the batch numbers are different.
Event or Problem Description
It was reported that labeling issue occurred.A 6.0mmx80mmx135cm-hybrid sterling was selected for use.However, during preparation, it was noted that the product inner pouch did not match the outer shelf carton.The procedure was completed using an alternate device.No patient complications were reported.

• 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: 19966685
• Report Number: 2124215-2024-46918
• Device Sequence Number: 7203261
• Product Code: LIT
• UDI-Device Identifier: 08714729845348
• UDI-Public: 08714729845348
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2024
• 2 Devices were Involved in the Event: 1 2

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: 05/14/2026
• Device Model Number: 24715
• Device Catalogue Number: 24715
• Device Lot Number: 0031620134
• 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: 07/16/2024
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2023
• 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