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	11/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in mildly tortuous and moderately calcified iliac artery.A 3.0mm x 40mm x 135cm (4f) sterling balloon catheter was advanced for dilatation.However, during the initial inflation at 5 atmospheres in 2 seconds, the balloon was ruptured, and it was observed near the balloon tip shoulder.The device was removed without any problem and the procedure was completed with different device.There were no patient complications nor injuries reported and the patient condition was good.
Event or Problem Description
It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in mildly tortuous and moderately calcified iliac artery.A 3.0mm x 40mm x 135cm (4f) sterling balloon catheter was advanced for dilatation.However, during the initial inflation at 5 atmospheres in 2 seconds, the balloon was ruptured, and it was observed near the balloon tip shoulder.The device was removed without any problem and the procedure was completed with different device.There were no patient complications nor injuries reported and the patient condition was good.
Additional Manufacturer Narrative
1.Lot number from unknown to 0029334246.2.Expiration date from unknown to 05/03/2025.3.Unique identifier (udi) from unknown to (b)(4).E1 initial reporter first name has been added.

• 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: 15826049
• Report Number: 2124215-2022-47826
• Device Sequence Number: 6005055
• Product Code: DQY
• UDI-Device Identifier: 08714729756880
• UDI-Public: 08714729756880
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2022

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: 05/03/2025
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0029334246
• 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: 11/15/2022
• Supplement Date Received by Manufacturer: 11/23/2022
• Initial Report FDA Received Date: 11/18/2022
• Supplement Report FDA Received Date: 11/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE USED: JUPITER.; GUIDEWIRE USED: JUPITER.; INFLATION DEVICE USED: NIPRO.; INFLATION DEVICE USED: NIPRO.; INTRODUCER SHEATH USED: PARENT 60.; INTRODUCER SHEATH USED: PARENT 60.; MICRO CATHETER: PROMINENT NEO.; MICRO CATHETER: PROMINENT NEO.
• Patient Sex: Unknown