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

Model Number	24716
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device entrapment occurred.The target lesion was located in the left superficial femoral artery.A 6.0x220x150-hybrid sterling balloon catheter was advanced over a 0.009 rotawire guidewire for dilatation.However, during the procedure, the balloon catheter would not track when it was attempted to be removed over the guidewire.A 0.014 v-14 guidewire was placed but the balloon catheter was still unable to be removed.The physician noted that it felt tight.The entire system was removed and the lesion was rewired.A 7.0x150x150-hybrid sterling balloon catheter was used and removed without incident; however, it was difficult to advance through the sheath when it was reinserted.The device was removed and the procedure was completed a different device.No patient complications were reported.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12272074
• Report Number: 2134265-2021-09671
• Device Sequence Number: 17027264
• Product Code: LIT
• UDI-Device Identifier: 08714729845485
• UDI-Public: 08714729845485
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K132430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/03/2021

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: 05/11/2024
• Device Model Number: 24716
• Device Catalogue Number: 24716
• Device Lot Number: 0027295224
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 08/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1