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

Model Number	2747
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that detachment occurred.The patient presented with arrhythmia for biventricular implantable cardioverter defibrillator (icd) insertion.A 182 cm j luge guidewire was selected for use in preparing the vessel for insertion of a pacer lead.During wiring using the 182cm j luge guidewire, it was noted that the proximal part of the radiopaque tip had detached.The physician decided to leave the broken piece inside the patient and no removal attempts were made.The procedure was completed with a different wire.The patient remained hemodynamically stable throughout the procedure.
Event or Problem Description
It was reported that detachment occurred.The patient presented with arrhythmia for biventricular implantable cardioverter defibrillator (icd) insertion.A 182 cm j luge guidewire was selected for use in preparing the vessel for insertion of a pacer lead.During wiring using the 182cm j luge guidewire, it was noted that the proximal part of the radiopaque tip had detached.The physician decided to leave the broken piece inside the patient and no removal attempts were made.The procedure was completed with a different wire.The patient remained hemodynamically stable throughout the procedure.It was further reported that the target vessel is posterior lateral branch of the coronary sinus, and they were unable to safely remove the device due to its location.
Additional Manufacturer Narrative
G2 report source: corrected.
Additional Manufacturer Narrative
The device was returned for analysis.Visual inspection revealed the proximal section was kinked and microscopic inspection revealed the distal tip was detached.A media inspection performed on pictures provided by the site showed evidence that could relate to the alleged failure.
Event or Problem Description
It was reported that detachment occurred.The patient presented with arrhythmia for biventricular implantable cardioverter defibrillator (icd) insertion.A 182 cm j luge guidewire was selected for use in preparing the vessel for insertion of a pacer lead.During wiring using the 182cm j luge guidewire, it was noted that the proximal part of the radiopaque tip had detached.The physician decided to leave the broken piece inside the patient and no removal attempts were made.The procedure was completed with a different wire.The patient remained hemodynamically stable throughout the procedure.It was further reported that the target vessel was in the posterior lateral branch of the coronary sinus, and that they were unable to safely remove the device due to its location.

• Brand Name: LUGE
• 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: 17590906
• Report Number: 2124215-2023-44851
• Device Sequence Number: 6467052
• Product Code: DQX
• UDI-Device Identifier: 08714729252337
• UDI-Public: 08714729252337
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K143587
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/20/2023

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: 08/30/2023
• Device Model Number: 2747
• Device Catalogue Number: 2747
• Device Lot Number: 0027934405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/10/2023
• Supplement Date Received by Manufacturer: 08/21/2023; 09/13/2023
• Initial Report FDA Received Date: 08/21/2023
• Supplement Report FDA Received Date: 09/08/2023; 09/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown