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

Model Number	24690
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device perforation occurred.A 6.0mmx20mmx135cm (4f) sterling balloon catheter was selected for treatment.During preparation, aspiration was done, and bubbles were noticed continuously coming back into the syringe.Per the report, it is likely an underlying perforation in the packaging.Due to this, preparation was not done.No patient complications were reported.
Event or Problem Description
It was reported that device perforation occurred.A 6.0mmx20mmx135cm (4f) sterling balloon catheter was selected for treatment.During preparation, aspiration was done, and bubbles were noticed continuously coming back into the syringe.Per the report, it is likely an underlying perforation in the packaging.Due to this, preparation was not done.No patient complications were reported.It was further reported that the procedure was completed with another of the same device.
Additional Manufacturer Narrative
B5.Describe event or problem: was updated per the additional information provided.E1 - initial repoter zip/post code: (b)(6).
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed a hole to the guidewire lumen 7mm from the tip.B5.Describe event or problem: was updated per the additional information provided.E1 - initial reporter zip/post code: (b)(6).
Event or Problem Description
It was reported that device perforation occurred.A 6.0mmx20mmx135cm (4f) sterling balloon catheter was selected for treatment.During preparation, aspiration was done, and bubbles were noticed continuously coming back into the syringe.Per the report, it is likely an underlying perforation in the packaging.Due to this, preparation was not done.No patient complications were reported.It was further reported that the procedure was completed with another of the same device.

• 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: 19714882
• Report Number: 2124215-2024-42631
• Device Sequence Number: 8778359
• Product Code: DQY
• UDI-Device Identifier: 08714729757252
• UDI-Public: 08714729757252
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/23/2024

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: 0033739057
• 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: 06/14/2024
• Supplement Date Received by Manufacturer: 07/12/2024; 08/29/2024
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 08/05/2024; 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2024
• 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