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

Model Number	10594
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon had a hole.A stingray lp re-entry device was selected for use.During preparation, it was noted that the balloon had a hole.The device never entered the patient's body.No complications were reported.
Event or Problem Description
It was reported that the balloon had a hole.A stingray lp re-entry device was selected for use.During preparation, it was noted that the balloon had a hole.The device never entered the patient's body.No complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The device was microscopically and visually examined.There was contrast in the inflation lumen.Inspection of the device presented no damage or irregularities.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.The device inflated and deflated to rated burst pressure with no issue.Functional testing was used to view the lumen and balloon for any leak damage.Product analysis could not confirm reported event as the device inflated to rated burst pressure and deflated with no issue and no damage was found to the device.

• Brand Name: STINGRAY LP
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12451590
• Report Number: 2134265-2021-11450
• Device Sequence Number: 1180635
• Product Code: DQY
• UDI-Device Identifier: 08714729903352
• UDI-Public: 08714729903352
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2021

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: 05/14/2023
• Device Model Number: 10594
• Device Catalogue Number: 10594
• Device Lot Number: 0027315418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2021
• Supplement Date Received by Manufacturer: 11/04/2021
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown