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

Model Number	2779
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/09/2023
Type of Reportable Event	Death
Event or Problem Description
It was reported that tip detachment and patient death occurred.The patient declined surgery and opted for high-risk percutaneous coronary intervention (pci) for multi vessel disease treatment.A 185cm pt2 guidewire was selected for use.The 75% stenosed target lesion was located in the non-tortuous and moderately to severely calcified left main (lm).Two non-boston scientific stents were deployed, one in the right coronary artery and another in the lm.However, upon removal of the pt2 wire through the stent in the lm, resistance was felt, and the tip of the wire broke.The tip was not retrieved, and angiogram showed it was in the distal obtuse marginal.No additional intervention was performed after the tip of the wire broke.The procedure was completed successfully.The patient was stable post procedure but died later on the same day.

• Brand Name: PT
• 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; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18030877
• Report Number: 2124215-2023-57640
• Device Sequence Number: 6961915
• Product Code: DQX
• UDI-Device Identifier: 08714729471189
• UDI-Public: 08714729471189
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K030617
• 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): 10/30/2023

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: 05/31/2025
• Device Model Number: 2779
• Device Catalogue Number: 2779
• Device Lot Number: 0031732338
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/12/2023
• Initial Report FDA Received Date: 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2023
• 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: Death
• Patient Sex: Female