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

Model Number	24690
Medical Device Problem Codes	Component Missing (2306); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that tip detachment occurred.A 3.0 mm x 30 mm x 135 cm (4f) sterling balloon was selected for dilation.However, when preparing for the procedure, it was noted that a piece of the tip was missing and it was incomplete.The procedure was completed with another of the same device.The patient's condition following the procedure was stable.
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).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 and microscopic examination revealed no damages.The packaging did not return for analysis.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis could not confirm the reported tip missing.
Event or Problem Description
It was reported that tip detachment occurred.A 3.0mmx30mmx135cm (4f) sterling balloon was selected for dilation.However, when preparing for the procedure, it was noted that a piece of the tip was missing and it was incomplete.The procedure was completed with another of the same device.The patient's condition following the procedure was stable.It was further reported that the tip was not detached, but a piece was missing.Furthermore, no anomalies were noted with the pouch prior to use, nor had it been previously opened or used.An attempt was made to visualize the missing piece of the tip under fluoroscopy, but it could not be found.

• 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: 20982801
• Report Number: 2124215-2024-78682
• Device Sequence Number: 18396746
• Product Code: DQY
• UDI-Device Identifier: 08714729756873
• UDI-Public: 08714729756873
• 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): 01/17/2025

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: 0033411375
• 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: 12/05/2024
• Supplement Date Received by Manufacturer: 12/26/2024
• Initial Report FDA Received Date: 12/19/2024
• Supplement Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2024
• 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 Age: 56 YR
• Patient Sex: Male
• Patient Weight: 72 KG