MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) WEBSTER CS CATHETER WITH EZ-STEER TECHNOLOGY AND AUTO ID; ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE

Model Number D-1263-07-S

Device Problems Unsealed Device Packaging (1444); Device Packaging Compromised (2916)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/22/2016

Event Type  malfunction  

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a webster cs catheter with ez-steer technology and auto id and an open package was discovered.While setting up for the case, it was noticed that the catheter's packaging was opened and was possibly contaminated.The product was not used in the patient.The catheter was replaced and the issue resolved.The procedure was completed with no patient consequence.This event was assessed as mdr reportable because a packaging defect that compromises the sterility of the product exposes patients to the possibility of the introduction of microorganisms into the vasculature, potentially leading to an infectious process, bacteremia, or sepsis.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrial fibrillation procedure with a webster cs catheter with ez-steer technology and auto id and an open package was discovered.Upon receipt, the catheter was visually inspected and it was found in normal conditions.Since the original packaging was not returned and there are no pictures available, no further investigation could be performed.However, during manufacturing process several on line inspections are in place to prevent this type of damage/defect from leaving the facility.The complaints database was reviewed for the complaint lot number and no other complaint associate with the issue reported was found.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.The customer complaint cannot be confirmed.

• Brand Name: WEBSTER CS CATHETER WITH EZ-STEER TECHNOLOGY AND AUTO ID
• Type of Device: ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE
• 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 ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 5794957
• MDR Text Key: 50520770
• Report Number: 9673241-2016-00439
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: D-1263-07-S
• Device Catalogue Number: BD710DF282CT
• Device Lot Number: 17439744M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/22/2016
• Initial Date FDA Received: 07/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1