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	08/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified iliac vessel.A 4.5mm x 15mm quantum maverick balloon catheter was advanced for dilatation.However, during the initial inflation at 8 atmospheres for 10 seconds, the balloon ruptured.The device was removed and a pinhole was noted at the center of the balloon.The procedure was completed with a different device.There were no patient complications reported and the patient was in good condition.
Additional Manufacturer Narrative
Corrections (b5) include what was initially reported and the corrected information of quantum maverick balloon catheter initially reported and the correct device should have been a sterling balloon catheter.(d1)brand name corrected from quantum maverick to sterling.(d2a) common device name corrected from catheters, transluminal coronary angioplasty, percutaneous to catheter, percutaneous.(d2b) pro code (product code) corrected from lox to dqy.(d4) model number corrected from 7015 to 24700.(d4) lot number corrected from 0026928291 to 0026928297.(d4) catalog number corrected from 7015 to 24700.(d4) unique identifier (udi) # corrected from (b)(4).
Event or Problem Description
It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified iliac vessel.A 10.0mmx20mmx135cm sterling balloon catheter was advanced for dilatation.However, during initial inflation at 8 atmospheres for 10 seconds, the balloon ruptured.The device was removed and a pinhole was noted.The procedure was completed with a different device.There were no patient complications nor injuries reported and the patient was in good condition.

• 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: 15324719
• Report Number: 2124215-2022-33372
• Device Sequence Number: 12234429
• Product Code: DQY
• UDI-Device Identifier: 08714729123408
• UDI-Public: 08714729123408
• 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): 09/07/2022
• 2 Devices were Involved in the Event: 1 2

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: 03/07/2024
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0026928297
• 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: 08/26/2022
• Supplement Date Received by Manufacturer: 08/26/2022
• Initial Report FDA Received Date: 08/30/2022
• Supplement Report FDA Received Date: 09/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2021
• 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