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

Model Number	24703
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/18/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that foreign matter was present in the packaging.A 2.0mm x 150mm x 90cm sterling sl balloon was selected for a procedure in the right leg artery.Upon unpacking, a hair was found inside the sterile bag.A different balloon was used to complete the procedure.There were no patient complications reported.

• 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: 11117737
• Report Number: 2134265-2020-18760
• Device Sequence Number: 4042080
• Product Code: DQY
• UDI-Device Identifier: 08714729782414
• UDI-Public: 08714729782414
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K093720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/05/2021

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: 08/25/2022
• Device Model Number: 24703
• Device Catalogue Number: 24703
• Device Lot Number: 0025910936
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/18/2020
• Initial Report FDA Received Date: 01/05/2021
• Patient Sequence Number: 1