MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STINGRAY; WIRE, GUIDE, CATHETER

Model Number	10598
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Perforation of Vessels (2135)
Date of Event	04/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a vessel perforation occurred.The target lesion was located in the left anterior descending artery (lad).A 185cm stingray guidewire was selected for use.During the procedure, it was noted that the wire perforated the left anterior descending artery causing the patient to experience hypotension.A balloon was used to treat the perforation and a pericardiocentesis was performed.The patient was stable post procedure and expected to fully recover.However, the procedure was not completed due to this event and coronay artery bypass graft (cabg) surgery was planned.

• Brand Name: STINGRAY
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 500 commander shea boulevard; quincy MA 02171
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19235125
• Report Number: 2124215-2024-23771
• Device Sequence Number: 6015635
• Product Code: DQX
• UDI-Device Identifier: 08714729837541
• UDI-Public: 08714729837541
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K122795
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/10/2025
• Device Model Number: 10598
• Device Catalogue Number: 10598
• Device Lot Number: 0032718202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2024
• Initial Report FDA Received Date: 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown