MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_SMART TOUCH BIDIRECTIONAL; SIMILAR DEVICE D132701, PMA # P030031/S053

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

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

Patient Problem Pseudoaneurysm (2605)

Event Date 01/01/2019

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.Cerenovus manufacturer's report numbers: 2029046-2020-00075 and 2029046-2020-00076 are related to the same incident.

Event Description

This complaint is from a literature source.As reported in the literature publication entitled, ¿the electrical isolation of the left atrial posterior wall in catheter ablation of persistent atrial fibrillation¿ (pmid:31753429).2 patients with persistent atrial fibrillation who underwent catheter ablation with cpvi (circumferential pulmonary vein isolation) with a posterior wall box isolation (pobi group) experienced pseudoaneurysm.Objectives this study explored whether complete electrical isolation of the left atrial (la) posterior wall improves the rhythm outcome of catheter ablation of persistent atrial fibrillation (af).Methods we randomly assigned 217 patients with persistent af (83.1% men, age 58.7 _ 10.8 years, 73.3% longstanding persistent af) to ablation with cpvi alone (cpvi group) or cpvi with a posterior wall box isolation (pobi group).The endpoint of the pobi group was the elimination of the posterior atrial potentials by roof and posterior inferior lines and touch-up focal ablation.Bwi devices (thermocool smart touch catheters) were used in this study.No devices specific information (including catalog and lot number) were provided in the article.Concomitant devices were: carto3 mapping system, navx mapping system date of publication: november 2019.

• Brand Name: UNK_SMART TOUCH BIDIRECTIONAL
• Type of Device: SIMILAR DEVICE D132701, PMA # P030031/S053
• 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: 9581687
• MDR Text Key: 189494721
• Report Number: 2029046-2020-00077
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 12/20/2019

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_SMART TOUCH BIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2019
• Initial Date FDA Received: 01/13/2020
• 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: 59 YR