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

Model Number	H74939032601010
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 80% stenosed target lesion was located in the severely tortuous and severely calcified superficial femoral artery.A 6.0mmx100mmx135cm-hybrid sterling balloon catheter was advanced for dilatation.However, during the first inflation at 8 atmospheres for a couple of seconds, the balloon ruptured.The whole balloon system was removed, and the procedure was completed with another sterling balloon catheter.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a sterling balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed a longitudinal tear in the balloon 8mm from the tip and is approximately 65mm long.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there is a longitudinal tear in the balloon.
Event or Problem Description
It was reported that balloon rupture occurred.The 80% stenosed target lesion was located in the severely tortuous and severely calcified superficial femoral artery.A 6.0mmx100mmx135cm-hybrid sterling balloon catheter was advanced for dilatation.However, during the first inflation at 8 atmospheres for a couple of seconds, the balloon ruptured.The whole balloon system was removed, and the procedure was completed with another sterling balloon catheter.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a sterling balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed a longitudinal tear in the balloon 8mm from the tip and is approximately 65mm long.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there is a longitudinal tear in the balloon.This report is being filed to correct the model number and unique identifier (udi) # in response to an fda request.
Event or Problem Description
It was reported that balloon rupture occurred.The 80% stenosed target lesion was located in the severely tortuous and severely calcified superficial femoral artery.A 6.0mmx100mmx135cm-hybrid sterling balloon catheter was advanced for dilatation.However, during the first inflation at 8 atmospheres for a couple of seconds, the balloon ruptured.The whole balloon system was removed, and the procedure was completed with another sterling balloon catheter.There were no patient complications reported.

• 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: 17964651
• Report Number: 2124215-2023-57661
• Device Sequence Number: 20530760
• Product Code: DQY
• UDI-Device Identifier: 08714729123682
• UDI-Public: (01)08714729123682(17)260202(10)30980794
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/02/2024

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: 02/02/2026
• Device Model Number: H74939032601010
• Device Catalogue Number: 24700
• Device Lot Number: 0030980794
• 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: 10/10/2023
• Supplement Date Received by Manufacturer: 11/09/2023; 06/12/2024
• Initial Report FDA Received Date: 10/19/2023
• Supplement Report FDA Received Date: 11/21/2023; 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2023
• 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 Sex: Unknown