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

Model Number	24700
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in a moderately tortuous and moderately calcified vessel in the left forearm.A 8.0mmx40mmx80cm sterling balloon catheter was advanced for dilatation.However, during initial inflation at 10 atmospheres for 30 seconds, the balloon ruptured.The device was removed without any problem and the procedure was completed with a different device.There were no patient complications nor injuries reported and the patient was in good condition post-procedure.
Additional Manufacturer Narrative
(b)(6).
Additional Manufacturer Narrative
Updated b5: describe event or problem (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in a moderately tortuous and moderately calcified vessel in the left forearm.A 8.0mmx40mmx80cm sterling balloon catheter was advanced for dilatation.However, during initial inflation at 10 atmospheres for 30 seconds, the balloon ruptured.The device was removed without any problem and the procedure was completed with a different device.There were no patient complications nor injuries reported and the patient was in good condition post-procedure.It was further reported that a 8.0mmx40mmx80cm and a 6.0mmx40mmx40cm sterling balloon catheters were used in the same patient and procedure.A 8.0mmx40mmx80cm sterling balloon was used first and second was a 6.0mmx40mmx40cm sterling balloon catheter.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15422499
• Report Number: 2124215-2022-35900
• Device Sequence Number: 2556311
• Product Code: DQY
• UDI-Device Identifier: 08714729720690
• UDI-Public: 08714729720690
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2022

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: 06/07/2025
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0029548119
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/12/2022
• Supplement Date Received by Manufacturer: 09/16/2022
• Initial Report FDA Received Date: 09/14/2022
• Supplement Report FDA Received Date: 09/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2022
• 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