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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOSENSE WEBSTER INC PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE INTRODUCER, CATHETER

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BIOSENSE WEBSTER INC PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE INTRODUCER, CATHETER Back to Search Results
Catalog Number UNK_PREFACE SHEATH
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Pseudoaneurysm (2605); Thrombosis/Thrombus (4440)
Event Date 10/01/2021
Event Type  Injury  
Manufacturer Narrative
Manufacturer's ref. No: (b)(4). This complaint is from a literature source. The following literature cite has been reviewed: jiang li xiaomei, zhang yi li meiting , liu haiju li hao, zhou yiming. Radiofrequency ablation of 328 cases of pediatric idiopathic arrhythmia in recent 5 years in a single center. Chinese journal of practical pediatrics, october 2021, vol. 36, no. 19, chinjapplclinpediatr, october2021, vol. 36, no. 19. Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed. Manufacturing record evaluation (mre) cannot be conducted because no lot number was not 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.
 
Event Description
This complaint is from a literature source. The following literature cite has been reviewed: jiang li xiaomei, zhang yi li meiting , liu haiju li hao, zhou yiming. Radiofrequency ablation of 328 cases of pediatric idiopathic arrhythmia in recent 5 years in a single center. Chinese journal of practical pediatrics, october 2021, vol. 36, no. 19, chinjapplclinpediatr, october2021, vol. 36, no. 19. Objective/methods/study data: objective to investigate the electrophysiological characteristics and radiofrequency ablation effect of idiopathic arrhythmia (vas) in children. Methods from january 2014 to december 2019, 328 children with idiopathic vas underwent radiofrequency ablation in the first affiliated hospital of tsinghua university, including 205 males and 123 females; age (7. 8 ± 3. 9) years; body mass (32. 8 ± 17. 7) kg. The electrophysiological characteristics and radiofrequency ablation results of vas at different origin sites in children were analyzed. As a result, the age of first onset of the 328 children was (5. 4 ± 4. 1), frequent extra systoles accounted for 57. 6%, non-sustained tachycardia accounted for 28. 7%, persistent tachycardia accounted for 13. 7%; 38 patients with tachycardia-induced cardiomyopathy (11. 6%, 38/328). Of the 328 children, except for 13 who failed to induce vas during surgery, 315 mapping confirmed that vas originated from the outflow tract in 152 cases (152/328 cases, 46. 4%), including the right ventricular outflow tract septal site 46. 1%, left coronary sinus 27. 6%, right coronary sinus 18. 4%, right ventricular outflow tract free wall 7. 9%; tricuspid annulus in 55 patients (55/328 patients, 16. 5%); left posterior branch in 54 patients (54/328 patients, 17. 4%); 39 patients (39/328 patients, 11. 9%); 5 cases were multiple (5/328 cases, 1. 5%); left anterior branch in 3 cases (3/328 cases, 0. 9%); other 7 (7/328, 2. 1%). Radiofrequency ablation was performed in 307 patients (307/328 patients, 93. 6%), immediate success in 271 (271/307, 88. 3%), effective in 14 (14/307, 4. 6%), failure in 22 (22/307, 7. 2%). Conclusion the right ventricular outflow tract septum is the most common site of idiopathic vas originating from the outflow tract in children; the ablation effect of outflow tract and tricuspid annulus origin is good, and the recurrence rate of left ventricular branch type and left posterior papillary muscle origin is relatively high; radiofrequency ablation of idiopathic vas in infants is relatively safe and effective, but the surgical indications should be strictly grasped and operated by experienced pediatric electrophysiologists; three-dimensional mapping guided radiofrequency ablation can control the radiation dose in a very low safety range. Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: 8fr multifunctional sheath (johnson & johnson, usa). Will be coded as unk_preface sheath for reportability purposes. Other biosense webster concomitant devices that were also used in this study: -carto (johnson & johnson, usa). 7fr cold saline perfusion ablation catheter (johnson & johnson, usa). Will be considered concomitant as they note complications were vascular related therefore likely related to the sheath. Non-biosense webster concomitant devices that were also used in this study: n/a. Adverse event(s) and provided interventions: intraoperative related vascular complications occurred in 4 cases (4/328 cases); among them, 3 cases were right femoral artery stenosis ( this will be coded as vascular pseudoaneurysm) with thromboembolism ( this will be coded as thrombosis). 1 case of pseudoaneurysm was cured by surgical treatment. There was no further mention of interventions provided.
 
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Brand NamePREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE
Type of DeviceINTRODUCER, 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
michelleann garcia
31 technology dr
irvine, CA 92618
646591-798
MDR Report Key14945084
MDR Text Key295417212
Report Number2029046-2022-01532
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_PREFACE SHEATH
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/07/2022 Patient Sequence Number: 1
Treatment
7FR COLD SALINE PERFUSION ABLATION CATHETER (J&J); CARTO (JOHNSON & JOHNSON, USA)
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