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

Model Number	24694
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via facility medwatch# report mw5112057 that a shaft break occurred resulting in surgical intervention.The 99% stenosed target lesion with a bend of <45 degrees was located in the non-tortuous and severely calcified anterior tibial vessel of the right leg.A 3.0mmx220mmx150cm (4f) sterling balloon catheter was advanced for dilatation.After dilatation, the balloon catheter was withdrawn; however, it was discovered that the balloon and part of the catheter where it is mounted to were broken off and remained in the patient's blood vessel.The rest of the catheter and sheaths were removed from the patient's left groin and pressure was held until hemostasis was achieved.The patient was taken to the operating room for surgical removal of fractured catheter and possible bypass surgery.Eventually, the fractured portion was successfully removed by surgical removal.There were no patient complications reported as the patient status was stable post-procedure and was discharged.

• 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: 15675114
• Report Number: 2124215-2022-40831
• Device Sequence Number: 15063694
• Product Code: LIT
• UDI-Device Identifier: 08714729859208
• UDI-Public: 08714729859208
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/06/2025
• Device Model Number: 24694
• Device Catalogue Number: 24694
• Device Lot Number: 0028817203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2022
• Initial Report FDA Received Date: 10/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown