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	08/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter city: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed target lesion was located in mildly tortuous and severely calcified right superficial artery.After a non-boston scientific (bsc) introducer sheath was inserted and the lesion crossed with non-bsc guidewire.A 3.0mmx20mmx135cm (4f) sterling balloon catheter was advanced for dilatation.The device crossed the lesion and initial inflation was performed at 6 atmospheres in 10 seconds; however, the balloon ruptured at the middle part.The device was removed without any problem and the procedure was completed with non-bsc device and good dilation was obtained.There were no patient complications nor injuries reported and the patient condition was good.

• 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: 15180045
• Report Number: 2124215-2022-29140
• Device Sequence Number: 17703346
• Product Code: DQY
• UDI-Device Identifier: 08714729755586
• UDI-Public: 08714729755586
• 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
• Report Date (Section B): 08/05/2022

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: 07/11/2023
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0025685803
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/03/2022
• Initial Report FDA Received Date: 08/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BALLOON CATHETER USED: SHIDEN HP 4MM4CM; GUIDEWIRE USED: CRUISE 0.014 INCH; INFLATION DEVICE USED: EVEREST; INTRODUCER SHEATH USED: DESTINATION 6F
• Patient Sex: Unknown