MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. INQUIRY ¿ STEERABLE DIAGNOSTIC CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number IBI-81531

Device Problem Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Type  malfunction  

Event Description

The following was published in the 2214-0271/© 2022 heart rhythm society.Published by elsevier inc.In an article titled "coronary sinus spasm with catheter entrapment and adjacent coronary artery compression during an ablation procedure in a child".2022-08-01, volume 38, issue 8, pages 1277-1285, copyright © 2022 canadian cardiovascular society, christophe vo.A 6-year-old girl weighing 39.7 kg was referred for catheter ablation in the setting of paroxysmal supraventricular tachycardia, a structurally normal heart, and no ventricular preexcitation.Supraventricular tachycardia was first documented at 2 years of age, with frequent recurrent bouts despite antiarrhythmic drug therapy.Episodes often terminated with vagal maneuvers but occasionally required intravenous adenosine.The catheter tip became entrapped in the proximal coronary sinus at or near the ostium of the middle cardiac vein.Efforts to reposition or retract the catheter using gentle traction were futile.A deflectable sheath (6.5f destino twist; oscor, palm harbor, fl) was introduced in order to cannulate the coronary sinus for angiography.Attempts were unsuccessful with and without guidance by a second 4f steerable decapolar catheter within the sheath.The handle of the entrapped decapolar catheter was removed by cutting through the shaft to allow a 5f sheath (performer guiding sheath; cook medical, bloomington, in) to be positioned over the catheter and into the coronary sinus.Contrast injection through this sheath revealed complete obstruction of the proximal coronary sinus at the tip of the entrapped catheter, presumably owing to spasm (figure 1).Selective coronary angiography showed severe narrowing of the circumflex artery adjacent to the site of obstruction (figure 1c).The patient remained without ischemic changes on 12-lead electrocardiograms.The cardiac surgical team was contacted for onsite surgical backup and readiness.The sheath was advanced near the tip of the entrapped catheter.Careful traction with countertraction maneuvers failed to release the catheter.Nitroglycerin (2.5 mcg/kg) was administered through the long sheath in the coronary sinus while applying traction and countertraction.The coronary sinus spasm subsided within 5 minutes and the decapolar catheter was freed.On inspection, no tissue was adherent to the tip of the retrieved catheter.Repeat coronary angiography showed restoration of unimpeded flow to the circumflex artery, normal venous return via the coronary sinus, and no evidence of coronary sinus dissection (figure 2).No pericardial effusion was noted by ¿quick-look¿ transthoracic echocardiography.The electrophysiological study was resumed without a diagnostic catheter placed in the coronary sinus.Orthodromic atrioventricular reentrant tachycardia via a concealed left lateral accessory pathway was diagnosed.The accessory pathway was successfully ablated by means of a retrograde aortic approach (figure 3), as per standard local practice.Throughout, the patient remained hemodynamically stable and without ischemic electrocardiographic changes.Postprocedural transthoracic echocardiography was unremarkable, with no pericardial effusion or regional wall motion abnormality.The patient received an intravenous perfusion of heparin overnight in accordance with the institutional protocol for left-sided ablation procedures.She had an uneventful recovery and was discharged from hospital the following day with a 1-month prescription of aspirin (80 mg daily).At 3 months of follow-up, she remains arrhythmia-free off antiarrhythmic drugs.

Manufacturer Narrative

Correction.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Review of the device history record was not possible as the lot number is unknown.Based on the information received, the cause of the reported device entrapment remains unknown.

• Brand Name: INQUIRY ¿ STEERABLE DIAGNOSTIC CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16976432
• MDR Text Key: 315871931
• Report Number: 2030404-2023-00032
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K961924
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IBI-81531
• Device Catalogue Number: IBI-81531
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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