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	06/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the severely calcified internal carotid artery.A 5.5mmx40mmx135cm (4f) sterling balloon catheter was advanced for dilatation.However, during the procedure, the balloon ruptured and a leakage of the contrast agent was confirmed from the balloon part during inflation.The procedure was completed with a different device.No patient complications were reported.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the severely calcified internal carotid artery.A 5.5mmx40mmx135cm (4f) sterling balloon catheter was advanced for dilatation.However, during the procedure, the balloon ruptured and a leakage of the contrast agent was confirmed from the balloon part during inflation.The procedure was completed with a different device.No patient complications were reported.It was further reported that the balloon was inflated once.
Additional Manufacturer Narrative
E1 initial reporter city: (b)(6).

• 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: 14836695
• Report Number: 2134265-2022-07348
• Device Sequence Number: 20032135
• Product Code: DQY
• UDI-Device Identifier: 08714729757214
• UDI-Public: 08714729757214
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2022

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: 09/10/2023
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0025993984
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2022
• Supplement Date Received by Manufacturer: 07/25/2022
• Initial Report FDA Received Date: 06/27/2022
• Supplement Report FDA Received Date: 07/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2020
• 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