MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVISTAR; SIMILAR DEVICE NS7TCBL174HS, PMA # P990025

Catalog Number UNK_NAVISTAR

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

Patient Problem Pleural Effusion (2010)

Event Date 05/10/2010

Event Type  Injury  

Manufacturer Narrative

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 no lot number was provided by the customer.(b)(4).

Event Description

This complaint is from a literature source.It was reported that one patient underwent radiofrequency ablation and developed a hemothorax in group 2.Initially this event is assessed as a non-serious event.Additional information is received on 12/20/2017 indicating that this patient was (b)(6) female and required extended hospitalization.Physician¿s opinion regarding the causality of adverse event is procedure related and patient condition related.The event resulted in the mild impairment of a body function or damage to a body structure.Patient¿s condition is fully recovered (no residual effects).This event is re-assessed as serious injury and mdr reportable with new awareness date 12/20/2017.Title: ¿infarct transmurality as a criterion for first-line endo-epicardial substrate¿guided ventricular tachycardia ablation in ischemic cardiomyopathy¿ the purpose of this study was to investigate whether infarct transmurality (it) could identify patients who would benefit from a combined first-line endo-epicardial approach.Suspect device is a navistar, however catalog and lot number is unknown.

• Brand Name: NAVISTAR
• Type of Device: SIMILAR DEVICE NS7TCBL174HS, PMA # P990025
• 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: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 949789-383
• MDR Report Key: 7138383
• MDR Text Key: 95588996
• Report Number: 2029046-2017-01298
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/20/2017

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2017
• Initial Date FDA Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: No
• 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): Hospitalization
• Patient Age: 63 YR