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

Model Number	24703
Medical Device Problem Codes	Deflation Problem (1149); Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that the balloon failed to deflate.A 3.0mmx120mmx150cm sterling sl balloon was selected for a percutaneous transluminal angioplasty (pta) procedure.The target lesion was located below-the-knee (btk) with 85% stenosis.During the procedure inside the patient, the balloon failed to deflate properly after it was inflated.Several negative pressures were tried, but it was unable to not deflated.Upon removal, the balloon became stuck to the proximal part of the wire and the entire system was removed.The procedure was completed with another of the same device.There were no patient complications.

• Brand Name: STERLING SL
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9601797
• Report Number: 2134265-2020-00226
• Device Sequence Number: 3080233
• Product Code: DQY
• UDI-Device Identifier: 08714729782308
• UDI-Public: 08714729782308
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K093720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/17/2020

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: 06/27/2021
• Device Model Number: 24703
• Device Catalogue Number: 24703
• Device Lot Number: 0024028393
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 01/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1