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

Model Number	10594
Medical Device Problem Codes	Contamination (1120); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the sterility of the catheter was compromised.A stingray lp catheter was selected for use.Prior to the procedure, it was noted that the entire outside and inner package had a hole and the product sterility looked compromised.The device never entered the patient.The procedure was completed with another of same device.No patient complications were reported.

• Brand Name: STINGRAY LP
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11772734
• Report Number: 2134265-2021-05590
• Device Sequence Number: 3104689
• Product Code: DQY
• UDI-Device Identifier: 08714729903352
• UDI-Public: 08714729903352
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K152401
• 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): 05/04/2021

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: 03/17/2022
• Device Model Number: 10594
• Device Catalogue Number: 10594
• Device Lot Number: 0025367297
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 05/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1