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

Model Number	24716
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/14/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was difficult to remove.A 4f 2.5mm x 220mm x 90cm sterling balloon was selected for use in an angioplasty procedure.The balloon was introduced into the left leg.During the procedure, there was difficulty extracting the 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: 11056839
• Report Number: 2134265-2020-18257
• Device Sequence Number: 2975198
• Product Code: LIT
• UDI-Device Identifier: 08714729860082
• UDI-Public: 08714729860082
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K141112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/22/2020

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: 01/25/2022
• Device Model Number: 24716
• Device Catalogue Number: 24716
• Device Lot Number: 0025782539
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2020
• Initial Report FDA Received Date: 12/22/2020
• Patient Sequence Number: 1