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

Model Number	24690
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified artery in the c1 segment.A 6.0mmx30mmx135cm sterling balloon catheter was advanced in a routine manner, pumped the pressure back for several second and rapidly increased pressure until the balloon is fully formed.The radiography showed that the dilation of c1 segment was almost the same with the pre-operation, but the stenosis still remained.The balloon was re-dilated at 8 atmospheres, but the pressure pump was unsuccessfully pressurized.The device was withdrawn and found that the balloon burst.The procedure was completed with another of the same device.No complications were reported, and the patient was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: the sterling was returned for analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed a pinhole in the balloon 8mm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified artery in the c1 segment.A 6.0mmx30mmx135cm sterling balloon catheter was advanced in a routine manner, pumped the pressure back for several second and rapidly increased pressure until the balloon is fully formed.The radiography showed that the dilation of c1 segment was almost the same with the pre-operation, but the stenosis still remained.The balloon was re-dilated at 8 atmospheres, but the pressure pump was unsuccessfully pressurized.The device was withdrawn and found that the balloon burst.The procedure was completed with another of the same device.No complications were reported, and the patient was stable.

• 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: 18573752
• Report Number: 2124215-2024-03471
• Device Sequence Number: 7779465
• Product Code: DQY
• UDI-Device Identifier: 08714729757276
• UDI-Public: 08714729757276
• 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): 03/05/2024

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: 03/29/2026
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0031343073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/03/2024
• Supplement Date Received by Manufacturer: 02/14/2024
• Initial Report FDA Received Date: 01/24/2024
• Supplement Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2023
• 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 Age: 77 YR
• Patient Sex: Male
• Patient Weight: 67 KG