MAUDE Adverse Event Report: ABBOTT VASCULAR, INC. HI-TORQUE BALANCE HEAVYWEIGHT; WIRE, GUIDE, CATHETER

Model Number	1000462H
Health Effect - Clinical Codes	Hemothorax (1896); Patient Problem/Medical Problem (2688)
Date of Event	04/02/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
During procedure and prior to transseptal access, balance heavyweight wire noted to be broken.Fluoro confirmed distal tip in right ventricle/atrium.Interventional radiology team notified.Physicians attempted snare retrieval, without success.Physicians decided it best for patient (pt) to leave wire in place temporarily as pt was hemodynamically stable at the time and having no apparent arrhythmias related to the retained wire.Planned to bring pt back for retrieval at later time.Hours later, pt deteriorated with signs of hemopericardium and hemothorax.Determined that wire had migrated in pericardium to chest wall and abdomen.Sternotomy and exploratory laparotomy completed with retrieval of wire, no signs of major injury to other organs.Hemodynamic stability regained post-operatively.Electrophysiologist noted on closer inspection of this brand/model guidewire that there appears to be a weak spot.Ep lab has decided to no longer use this particular model guidewires for this ablation procedure.
Event or Problem Description
During procedure and prior to transseptal access, balance heavyweight wire noted to be broken.Fluoro confirmed distal tip in right ventricle/atrium.Interventional radiology team notified.Physicians attempted snare retrieval, without success.Physicians decided it best for patient (pt) to leave wire in place temporarily as pt was hemodynamically stable at the time and having no apparent arrhythmias related to the retained wire.Planned to bring pt back for retrieval at later time.Hours later, pt deteriorated with signs of hemopericardium and hemothorax.Determined that wire had migrated in pericardium to chest wall and abdomen.Sternotomy and exploratory laparotomy completed with retrieval of wire, no signs of major injury to other organs.Hemodynamic stability regained post-operatively.Electrophysiologist noted on closer inspection of this brand/model guidewire that there appears to be a weak spot.Ep lab has decided to no longer use this particular model guidewires for this ablation procedure.

• Brand Name: HI-TORQUE BALANCE HEAVYWEIGHT
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR, INC.; 3200 lakeside drive; santa clara CA 95054
• MDR Report Key: 8517703
• Report Number: 8517703
• Device Sequence Number: 1501449
• Product Code: DQX
• UDI-Device Identifier: 08717648015489
• UDI-Public: (01)08717648015489
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2019
• Report Date (Section F): 04/09/2019

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 Model Number: 1000462H
• Device Catalogue Number: 1000462H
• Device Lot Number: 8121171
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/16/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/16/2019
• Supplement Report FDA Received Date: 04/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Weight: 107
• Date Report Sent to FDA: 04/09/2019