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	03/23/2022
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 severely tortuous and moderately calcified radial vein.A 4.0mmx20mmx80cm (4f) sterling balloon catheter was advanced for dilatation.However, during initial inflation at 8 atmospheres for 10 seconds, the balloon ruptured vertically in the middle part.The device was removed without any problem and the procedure was completed with a different device.There were no patient complications reported and the patient status was good.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the severely tortuous and moderately calcified radial vein.A 4.0mmx20mmx80cm (4f) sterling balloon catheter was advanced for dilatation.However, during initial inflation at 8 atmospheres for 10 seconds, the balloon ruptured vertically in the middle part.The device was removed without any problem and the procedure was completed with a different device.There were no patient complications reported and the patient status was good.
Additional Manufacturer Narrative
Updated: d4: lot number.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13941036
• Report Number: 2134265-2022-03613
• Device Sequence Number: 6701748
• Product Code: DQY
• UDI-Device Identifier: 08714729123545
• UDI-Public: 08714729123545
• 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): 04/06/2022

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: 03/28/2022
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0023561297
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/24/2022
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2019
• 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