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 Cardiogenic Shock (2262)

Event Date 04/30/2019

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.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.  information regarding patient weight, height, medical history, race, and ethnicity was not reported.Biosense webster manufacturer's report numbers: 2029046-2020-00253.2029046-2020-00254.2029046-2020-00255.Are related to the same incident.

Event Description

This complaint is from a literature source.As reported in the literature publication entitled, ¿costs and long-term outcomes following pulmonary vein isolation for atrial fibrillation in elderly patients using second-generation cryoballoon vs.Open-irrigated radiofrequency in (b)(6)¿ (pmid:31893337).1 patient with drug-resistant paroxysmal or short-lasting persistent af, who underwent their first pulmonary vein isolation (pvi) using either the radiofrequency rf experienced the cardiogenic shock.

• 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: 9721670
• MDR Text Key: 192458296
• Report Number: 2029046-2020-00255
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• 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
• Date Manufacturer Received: 01/27/2020
• 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): Life Threatening
• Patient Age: 79 YR