MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_SMART TOUCH BIDIRECTIONAL SF; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Vascular Dissection (3160); Restenosis (4576)

Event Date 11/03/2022

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature cite has been reviewed singh v.; bugazia s.; gulati r.; deshmukh a.; erickson s.B.; hogan, m.C.: mayo clinic experience with endovascular renal denervation for kidney pain.06 nov 2022; [abstract].J am soc nephrol 33, 2022: 3 page(s).Objective and methods: the objective of this study was to evaluate outcomes following endovascular renal denervation (erd) for intractable kidney pain performed in patients from 1/2017-5/2022.Erd has been used in few medical centers to manage kidney pain and only reported in small case series.Method(s): retrospective & prospective analysis of 18 patients (with23 erds).Data included patient demographics, etiology, response to erd, time to recurrence of pain (visual analog scale) following first and/or second erd.After renal artery angiogram in the electrophysiology lab under general anesthesia, 8 fr sheath was placed in the femoral artery & renal artery cannulated using a destination sheath.Using smarttouch df catheters, serial, sequential ablation lesions were delivered in a spiral manner from distal to the ostium of renal arteries (power15-20w seeking impedance drop).Repeat renal angiogram was performed to ensure patency of the renal artery.Result(s): eighteen (13 f; 5m; median 42yo, range 23-71) had 23rdns (2 bilateral; 5 ipsilateral redos; median follow-up 33mo).Etiologies were loin pain hematuria (lphs) (n=5; 28%), nephrolithiasis (n=5;28%), pkd (n=5; 28%), reflux (n=1; 5%), nos (n=2; 11%).Five cases (28%) had recurrent ipsilateral pain at a median 21 mo.(range 6-28 mo.) after erd.Procedural complications include post-operative pain (n=8), dissection (n=2), retroperitoneal bleed (n=2), stenosis (n=1), where 1 patient experienced renal artery dissection after a repeat procedure.Five (all females) had no benefit from erd.Lot, model and catalog number are not available, but the suspected biosense webster device possibly associated with reported adverse events: smarttouch df.Other biosense webster devices that were also used in this study: cartosound.Adverse event(s) and interventions (possibly associated with biosense webster device(s)): 8 postop pain- no treatment specified, 2 unspecified dissections- no treatment specified, 1 renal artery dissection- no treatment specified, and 1 case of renal artery stenosis- no treatment specified.

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed singh v.; bugazia s.; gulati r.; deshmukh a.; erickson s.B.; hogan, m.C.: mayo clinic experience with endovascular renal denervation for kidney pain.06 nov 2022; [abstract].J am soc nephrol 33, 2022: 3 page(s).No device was received for analysis at the time of submission of the initial 3500a.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 the lot number was provided by the customer.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster inc, or its employees that the report constitutes an admission that the product, biosense webster inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer¿s reference number: (b)(4).

• Brand Name: UNK_SMART TOUCH BIDIRECTIONAL SF
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16462232
• MDR Text Key: 310462668
• Report Number: 2029046-2023-00423
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SMART TOUCH BIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2023
• 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
• Treatment: CARTOSOUND
• Patient Outcome(s): Life Threatening