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

Model Number	H749393120SR0
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.Used first day of the aware date as the event date was not provided.
Event or Problem Description
It was reported that a balloon rupture occurred.A stingray lp catheter was selected for use.During the procedure, it was noted that the balloon was ruptured.The procedure was completed with this device.There were no patient complications reported.
Additional Manufacturer Narrative
B3.Used first day of the aware date as the event date was not provided.Device evaluated by manufacturer: the device was returned for analysis.The device was visually and microscopically examined.There were numerous shaft kinks to the device.There was blood in the guidewire lumen and inflation lumen and the balloon was loosely folded.At 5.3cm from the tip of the device, the guidewire lumen was punctured indicating an interaction with a guidewire.
Event or Problem Description
It was reported that a balloon rupture occurred.A stingray lp catheter was selected for use.During the procedure, it was noted that the balloon was ruptured.There were no patient complications reported.
Event or Problem Description
It was reported that a balloon rupture occurred.A stingray lp catheter was selected for use.During the procedure, it was noted that the balloon was ruptured.There were no patient complications reported.
Additional Manufacturer Narrative
This report is being filed to correct the model number and unique identifier (udi) # in response to an fda request.B3.Used first day of the aware date as the event date was not provided.Device evaluated by manufacturer: the device was returned for analysis.The device was visually and microscopically examined.There were numerous shaft kinks to the device.There was blood in the guidewire lumen and inflation lumen and the balloon was loosely folded.At 5.3cm from the tip of the device, the guidewire lumen was punctured indicating an interaction with a guidewire.

• Brand Name: STINGRAY LP
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18406454
• Report Number: 2124215-2023-71955
• Device Sequence Number: 18323789
• Product Code: DQY
• UDI-Device Identifier: 08714729903352
• UDI-Public: (01)08714729903352(17)20250529(10)0031717887
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Followup
• Report Date (Section B): 07/25/2024

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: 05/29/2025
• Device Model Number: H749393120SR0
• Device Catalogue Number: 10594
• Device Lot Number: 0031717887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2023
• Supplement Date Received by Manufacturer: 01/15/2024; 07/09/2024
• Initial Report FDA Received Date: 12/27/2023
• Supplement Report FDA Received Date: 02/07/2024; 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2023
• 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