MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STERLING SL; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	24703
Medical Device Problem Codes	Entrapment of Device (1212); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device entrapment occurred.A lower extremity arterial balloon dilatation was performed, and the patient's anterior tibial artery was dilated after distal entry using a 2.5mm x 150mm x 150cm sterling sl balloon catheter.The device was removed from the body under negative pressure and the posterior tibial artery of the patient was reprocessed.The rupturing pressure was maintained for two minutes, and the balloon was unable to re-enter the lesion through the guidewire.The guidewire could not be taken out of the balloon.When the whole system was pulled out of the body, it was discovered that the guidewire could not be removed from the balloon.The balloon itself was twisted and could no longer be used.Another of the same device was used to complete the remainder of the procedure.There were no patient complications, and the patient status was stable post procedure.
Event or Problem Description
It was reported that device entrapment occurred.A lower extremity arterial balloon dilatation was performed, and the patient's anterior tibial artery was dilated after distal entry using a 2.5mm x 150mm x 150cm sterling sl balloon catheter.The device was removed from the body under negative pressure and the posterior tibial artery of the patient was reprocessed.The rupturing pressure was maintained for two minutes, and the balloon was unable to re-enter the lesion through the guidewire.The guidewire could not be taken out of the balloon.When the whole system was pulled out of the body, it was discovered that the guidewire could not be removed from the balloon.The balloon itself was twisted and could no longer be used.Another of the same device was used to complete the remainder of the procedure.There were no patient complications and the patient status was stable post procedure.It was further reported that the target lesion was mildly tortuous and mildly calcified.No additional intervention was performed when removing the balloon device.

• Brand Name: STERLING SL
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• 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: 19358676
• Report Number: 2124215-2024-28094
• Device Sequence Number: 20418675
• Product Code: DQY
• UDI-Device Identifier: 08714729782278
• UDI-Public: 08714729782278
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K093720
• 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): 06/06/2024

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: 10/30/2025
• Device Model Number: 24703
• Device Catalogue Number: 24703
• Device Lot Number: 0032756765
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2024
• Supplement Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2023
• 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
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 60 KG