MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) DEF TC IR 7FR 4P F LE 2-5-2; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number D-1189-03-S

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 06/21/2014

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.The device history record (dhr) has been reviewed and it was verified that device was manufactured in accordance with documented specifications and procedures.(b)(4).Methods: no testing methods performed.Results: no results available since no evaluation performed.Conclusion: device discarded by user, unable to follow-up.(b)(4) the device was not returned to bwi.

Event Description

This event is part of remarkable clinical study.It was reported that a (b)(6) male patient underwent pulmonary vein isolation procedure.The patient has a medical history of systematic atrial fibrillation and hypertension.The patient suffered pain in leg with convulsions more than 7 days after the procedure.The patient was treated with medication.Fentanyl iv was administered multiple times during the procedure to achieve a deep analgosedation.The issue was resolved without sequelae.The principal investigator assessed this event as definitely procedure related and not device related.The new awareness date of this event is 09/29/2015 because the event was assessed from not procedure-related to definitely procedure-related on 09/29/2015.

• Brand Name: DEF TC IR 7FR 4P F LE 2-5-2
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer Contact: joaquin kurz ; 15715 arrow highway; irwindale, CA 91706 ; 9497893837
• MDR Report Key: 5157185
• MDR Text Key: 28564770
• Report Number: 9673241-2015-00758
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Report Date: 09/18/2014

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 Expiration Date: 10/31/2016
• Device Model Number: D-1189-03-S
• Device Catalogue Number: DI7TCFLRT
• Device Lot Number: 16010046M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 73 YR