MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE

Catalog Number	1009661
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Perforation of Vessels (2135); Pericardial Effusion (3271)
Date of Event	08/11/2023
Type of Reportable Event	Serious Injury
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.The reported patient effect of perforation is listed in the hi-torque guide wires instruction for use as a known patient effect with use of this device.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined; however, the subsequent treatments appear to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the proximal circumflex (cx).The hi-torque bmw universal guide wire (gw) was placed in the 2nd obtuse marginal (om) artery, but moved more distal.Two xience skypoint stents were successfully implanted in the cx target lesion, followed by post-dilatation.When contrast was injected staining was noted from the om to the 2nd apex of the heart and a small perforation was noted at the location where the gw was parked, causing fast decomposition.An echo cardiogram revealed a pericardial effusion.The patient was showing loss of vitals and the start of cardiac arrest.The physician was able to remove blood from the pericardium, while reintroducing the patient blood at the same time, which stabilized the patient; however, the perforation was noted to not be resolved and leaking was still noted.Balloon inflations were performed at the perforation, but still did not seal the perforation.Due to the distal location and size of the perforation, the patient was not a candidate for a covered stent; therefore coiling was done to treat the perforation.The patient was transferred to the intensive care unit in stable condition.No additional information was provided.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005737652; road no.2 km 58.0 cruce dávila; barceloneta PR 00617
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 17674505
• Report Number: 2024168-2023-09581
• Device Sequence Number: 17736909
• Product Code: DQX
• UDI-Device Identifier: 08717648014345
• UDI-Public: 08717648014345
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K101011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/01/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2024
• Device Catalogue Number: 1009661
• Device Lot Number: 3012472
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2023
• Initial Report FDA Received Date: 09/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: STENT: SKYPOINT (X2)
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Male