MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRES

Model Number	1011880J
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a de novo lesion in the distal right coronary artery (rca) with moderate calcification.The 3.0x15mm xience stent delivery system (sds) was implanted in the posterior descending artery (pda).The physician then decided to perform angioplasty to the posterier lateral artery (pla).The hi-torque (ht) balance middleweight elite guide wire was used to cannulate the pla.When the ht bmw elite guide wire was in place, the 2.5x8mm xience skypoint stent delivery system (sds) failed to cross due to the anatomy and was removed.There were no other issues noted.The ht bmw elite guide wire was repositioned and had resistance during withdrawal.A microcatheter was attempted to be used to remove the guide wire and it was after removing the microcatheter that it was noted that the proximal portion close to the guide catheter fractured and was left in the rca.The patient was sent immediately to surgery on (b)(6) 2023 and after surgery was admitted to intensive care.On (b)(6) 2023, the patient had cardiorespiratory complications and could not be treated any further due to a "do not resuscitate" (dnr) documentation.The patient died.Angiography was not done.In the physician's opinion, the use of the xience skypoint stent and ht bmw elite guide wire did not cause or contribute to the cardiorespiratory complications or death.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents/complaints from this lot.The investigation was unable to determine a conclusive cause for the reported difficulties; however, the subsequent treatment appears to be related to the operational context of the procedure.Additionally, the patient was sent to surgery for removal of the separated portion of the guide wire.In the physician's opinion, the use of the ht bmw elite guide wire did not cause or contribute to the cardiorespiratory complications or death.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRES
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 16724428
• Report Number: 2024168-2023-03728
• Device Sequence Number: 12586136
• Product Code: DQX
• UDI-Device Identifier: 08717648144790
• UDI-Public: 08717648144790
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103101
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2023

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: 09/30/2024
• Device Model Number: 1011880J
• Device Catalogue Number: 1011880J
• Device Lot Number: 2101161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2023
• Supplement Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 05/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 3.0X15MM XIENCE STENT
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 89 KG