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

Model Number 1009664

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Angina (1710); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Perforation of Vessels (2135); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 11/16/2021

Event Type  Injury  

Event Description

This event was reported thru review of an article.The patient presented with a non-st elevation myocardial infarction (nstemi) and was noted to have left main trifurcation disease; however, refused to have coronary artery bypass graft surgery (cabg).The procedure was to treat the left anterior descending (lad), left circumflex, and the ramus arteries.An unspecified balance middle weight (bms) guide wire was advanced to the lad and the lesion was predilated with non-compliant balloons.Stenting was performed; however, final contrast injection revealed timi flow 3 with residual contrast staining in the distal lad.An echocardiogram showed no pericardial effusion.One hour after the procedure, the patient became hypotensive and echocardiography revealed mild to moderate pericardial effusion with tamponade.Emergent pericardiocentesis was performed, followed by angiogram, which showed persistent leakage at the distal lad and a perforation was noted due to the bmw guide wire.A non-abbott balloon was used to seal the perforation and the patient was stabilized.Five days later, the patient had sharp chest pain and recurrent pericardial effusion was found via echocardiogram.The patient was diagnosed with acute pericarditis and was treated with medication.During the three month follow up, the patient was noted to be asymptomatic.Details are listed in the attached article, titled "iatrogenic pericarditis and cardiac tamponade following distal wire perforation: serial case report".

Manufacturer Narrative

Date of event has been estimated.The udi is unknown because the part/lot number were not provided.The device location was not provided, and it is unknown if the device is returning for analysis.A follow-up report will be submitted with all additional relevant information.Literature attachment.Article title: iatrogenic pericarditis and cardiac tamponade following distal wire perforation: a serial case report.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.A conclusive cause for the reported perforation of vessels, infection, hypotension, pericardial effusion, cardiac tamponade, angina, and the relationship to the product, if any, cannot be determined; however, the subsequent unexpected medical intervention, medication, and hospitalization / prolonged hospitalization appear to be related to the operational context of the procedure.The reported patient effects of perforation and infection are listed in the hi-torque guide wires for ptca, pta, stents instruction for use as a known patient effects of coronary stenting procedures.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE
• Type of Device: 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: 15147776
• MDR Text Key: 297064217
• Report Number: 2024168-2022-08451
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 08717648118715
• UDI-Public: 08717648118715
• Combination Product (y/n): N
• Reporter Country Code: ID
• PMA/PMN Number: K072460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: 1009664
• Device Catalogue Number: 1009664
• Device Lot Number: 1052871
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 84 KG