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

Model Number	24700
Medical Device Problem Codes	Deflation Problem (1149); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that deflation issue occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified artery.An 8.0mmx20mmx80cm (4f) sterling balloon catheter was advanced for dilatation.Upon deflation, the balloon could not be deflated properly.The device was replaced with another product and completed the procedure.No complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis and completed the investigation.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 inflation lumen 32.3cm from the hub.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found no damage to the device that would have contributed to the reported event.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis and completed the investigation.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 inflation lumen 32.3cm from the hub.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found no damage to the device that would have contributed to the reported event.
Event or Problem Description
It was reported that deflation issue occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified artery.An 8.0mmx20mmx80cm (4f) sterling balloon catheter was advanced for dilatation.Upon deflation, the balloon could not be deflated properly.The device was replaced with another product and completed the procedure.No complications were reported.It was further reported that the target lesion was located in the abdominal aorta.The deflation failure occurred when the device was tested outside the patient before use.

• 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: 18933029
• Report Number: 2124215-2024-14236
• Device Sequence Number: 4591996
• Product Code: DQY
• UDI-Device Identifier: 08714729720645
• UDI-Public: 08714729720645
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2024

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 Expiration Date: 01/20/2026
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0030897007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/26/2024
• Supplement Date Received by Manufacturer: 04/02/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE USED - THRUWAY; GUIDEWIRE USED - THRUWAY; INFLATION DEVICE - BOSTON ANCHOR; INFLATION DEVICE - BOSTON ANCHOR; INTRODUCER SHEATH - TERUMO/GOA; INTRODUCER SHEATH - TERUMO/GOA
• Patient Sex: Unknown