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

Model Number	24690
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the balloon snapped off and stayed in the patient, requiring snaring for removal.A 6.0mmx60mmx135cm (4f) sterling balloon was used during an angioplasty of a fistula.During the procedure, it was noted that the distal catheter broke or snapped off and stayed in the patient.The physician had to snare it to get it out.No complications were reported.
Event or Problem Description
It was reported that the balloon snapped off and stayed in the patient, requiring snaring for removal.A 6.0mmx60mmx135cm (4f) sterling balloon was used during an angioplasty of a fistula.During the procedure, it was noted that the distal catheter broke or snapped off and stayed in the patient.The physician had to snare it to get it out.No complications were reported.It was further reported that the 70% stenosed target lesion was located in the mildly tortuous and non-calcified central vein.The procedure was completed using a 6x40 sterling.No complications were reported and the patient was stable post-procedure.

• 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: 18584116
• Report Number: 2124215-2024-03853
• Device Sequence Number: 8491592
• Product Code: DQY
• UDI-Device Identifier: 08714729757313
• UDI-Public: 08714729757313
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2024

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 Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0032875343
• 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: 01/22/2024
• Supplement Date Received by Manufacturer: 01/26/2024
• Initial Report FDA Received Date: 01/25/2024
• Supplement Report FDA Received Date: 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown