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

Model Number	24700
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter entrapment occurred.The patient underwent angioplasty of the 50% stenosed target lesion with mixed morphology located in the mildly to moderately tortuous and mildly calcified iliac artery.After gaining vascular access via the right common femoral artery with a 6fr sheath, a 300cm, 8cm v-18 control wire guidewire was advanced deep into the aorta and into the target lesion.A 7.0mmx40mmx135cm (4f) sterling balloon catheter was prepped and advanced over guidewire into the external iliac for pre-dilation.The balloon was inflated to 10 atmospheres and worked perfectly; however, during withdrawal, the balloon was stuck on the guidewire.Flushing, inflating, and deflating the balloon was tried but it would not come off the guidewire.The balloon and guidewire were pulled out intact together through the sheath and a new guidewire was used to access the lesion.The procedure was completed successfully.No patient complications were reported.
Event or Problem Description
It was reported that catheter entrapment occurred.The patient underwent angioplasty of the 50% stenosed target lesion with mixed morphology located in the mildly to moderately tortuous and mildly calcified iliac artery.After gaining vascular access via the right common femoral artery with a 6fr sheath, a 300cm, 8cm v-18 control wire guidewire was advanced deep into the aorta and into the target lesion.A 7.0mmx40mmx135cm (4f) sterling balloon catheter was prepped and advanced over guidewire into the external iliac for pre-dilation.The balloon was inflated to 10 atmospheres and worked perfectly; however, during withdrawal, the balloon was stuck on the guidewire.Flushing, inflating, and deflating the balloon was tried but it would not come off the guidewire.The balloon and guidewire were pulled out intact together through the sheath and a new guidewire was used to access the lesion.The procedure was completed successfully.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of a sterling balloon catheter with a guidewire stuck inside the device.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed buckling to the guidewire lumen 4cm and 8cm from the tip.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.

• 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: 17299509
• Report Number: 2124215-2023-34948
• Device Sequence Number: 3874862
• Product Code: DQY
• UDI-Device Identifier: 08714729124078
• UDI-Public: 08714729124078
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K053116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2023

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: 02/26/2026
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0031131680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/21/2023
• Supplement Date Received by Manufacturer: 07/11/2023
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2023
• 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 Sex: Unknown