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

Model Number	24700
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon detachment occurred.During unpacking of a 5.0mmx20mmx135cm (4f) sterling balloon catheter, while preparing the balloon for use, the technician noticed that the balloon looked separated from the shaft with little manipulation and application of negative pressure.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: returned product consisted of a sterling balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual and microscopic examination revealed no damages.The balloon is loosely folded and there is contrast in the balloon.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found no issue with the device.
Event or Problem Description
It was reported that balloon detachment occurred.During unpacking of a 5.0mmx20mmx135cm (4f) sterling balloon catheter, while preparing the balloon for use, the technician noticed that the balloon looked separated from the shaft with little manipulation and application of negative pressure.The procedure was completed with a different 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16870931
• Report Number: 2124215-2023-18200
• Device Sequence Number: 17508040
• Product Code: DQY
• UDI-Device Identifier: 08714729122838
• UDI-Public: 08714729122838
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K053116
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2023

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: 09/20/2025
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0030192005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2023
• Supplement Date Received by Manufacturer: 05/12/2023
• Initial Report FDA Received Date: 05/04/2023
• Supplement Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2022
• 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 Sex: Unknown