MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_NAVISTAR THERMOCOOL; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number UNK_NAVISTAR THERMOCOOL

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

Patient Problem Paralysis (1997)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Biosense webster manufacturer's report number 2029046-2020-00794 is related to the same incident.

Event Description

This complaint is from a literature source.As reported in the literature publication entitled ¿efficacy of hybrid therapy using prior administration of bepridil hydrochloride and cryoballoon ablation in patients with persistent atrial fibrillation.¿ 3 patients with persistent atrial fibrillation who underwent atrial fibrillation catheter ablation from non-recurrence group experienced phrenic nerve injury.Purpose of this study was to investigate the efficacy of pretreatment with bepridil prior to cryoballoon ablation (cba) with respect to clinical outcomes in patients with persistent atrial fibrillation.Methods: from november 2015 to april 2018 65 consecutive patients with peaf who underwent cba following pretreatment with bepridil hydrochloride (bepridil).Electrical cardioversion was additionally performed in cases involving the failure of pharmacological sinus restoration before cba.The primary endpoint was survival free from atrial tachyarrhythmia at the one-year follow-up, and the secondary endpoints were changes in p-wave morphology and left atrium diameter (lad) before cryoballoon ablation were retrospectively analyzed.

• Brand Name: UNK_NAVISTAR THERMOCOOL
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 10215126
• MDR Text Key: 198873295
• Report Number: 2029046-2020-00795
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/10/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK_NAVISTAR THERMOCOOL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/10/2020
• Initial Date FDA Received: 06/30/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR