MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC (IRWINDALE) NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING

Model Number D-1183-07-S

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/03/2014

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a navistar¿ electrophysiology catheter and the sensor at the top of the catheter pulled off.The procedure was completed without patient consequence.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.With the information at present we cannot conclude there were not internal parts exposed, therefore will be taking a conservative approach although there was no difficulty to remove the catheter from patient.Per 21 cfr, part 803, this complaint is reportable because this could potentially contribute to a death or serious 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.As such, the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.The device history record (dhr) review cannot be conducted because the no lot number was provided by the customer.Since the lot number is unknown, the full udi number cannot be provided.(b)(4).

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).

Manufacturer Narrative

(b)(4) it was reported that a patient underwent an atrial fibrillation procedure with a navistar electrophysiology catheter and the sensor at the top of the catheter pulled off.The procedure was completed without patient consequence.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.With the information at present we cannot conclude there were not internal parts exposed, therefore will be taking a conservative approach although there was no difficulty to remove the catheter from patient.The bwi failure analysis lab received the device for evaluation.Upon receipt, the catheter was visually inspected and it was found in normal conditions.The catheter tip does not show any damage.Then per the event, a deflection test was performed and the catheter performed within specifications.No evidence of detachment was observed on the sensor.The device history record(s) 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.

Manufacturer Narrative

During an internal review of this complaint on february 25, 2016, it was found that during the biosense webster analysis the lot number was retrieved from the catheter.The lot number is 17029852m.Therefore, the udi number is (b)(4).An internal corrective action has been opened to prevent this issue.(b)(4).

• Brand Name: NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER, INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer (Section G): BIOSENSE WEBSTER, INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer Contact: 15715 arrow highway; irwindale, CA 91706
• MDR Report Key: 4276109
• MDR Text Key: 5294464
• Report Number: 2029046-2014-00442
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P990025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/04/2014

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: 05/31/2017
• Device Model Number: D-1183-07-S
• Device Catalogue Number: NS7TCDL174HS
• Device Lot Number: UNKNOWN_D-1183-07-S
• Other Device ID Number: (01)10846835000597
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/04/2014
• Initial Date FDA Received: 11/25/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 01/19/2015; 07/03/2015; 03/23/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/19/2014
• 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