MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) LASSO¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING

Model Number D-1220-38-S

Device Problems Component Missing (2306); Malposition of Device (2616); Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/23/2014

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a lasso¿ electrophysiology catheter and had visualization issues.There was no patient consequence.During procedure, the platinum point of the catheter could not be found on the system.The procedure was completed successfully by exchanging the catheter.This event is being reported because the bwi failure analysis lab received the device for evaluation and found that ring #1 is lifted and that pu donut is not covering the transition between the ring and spine cover.There is no foreign material observed however, sharp edge is noticeable.This finding is reportable because this poses a risk to the patient.This event was originally considered non-reportable, however, bwi became aware of the product returned condition on (b)(6) 2014 and have reassessed the event as reportable.

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.(b)(4).

Manufacturer Narrative

(b)(4) it was reported that a patient underwent an atrial fibrillation procedure with a lasso electrophysiology catheter and had visualization issues.There was no patient consequence.During procedure, the platinum point of the catheter could not be found on the system.The procedure was completed successfully by exchanging the catheter.This event is being reported because the bwi failure analysis lab received the device for evaluation and found that ring # 1 is lifted and that pu donut is not covering the transition between the ring and spine cover.There is no foreign material observed however, sharp edge is noticeable.This finding is reportable because this poses a risk to the patient.The bwi failure analysis lab received the device for evaluation.Upon receipt, the catheter was visually inspected and it was found that ring # 1 was damaged.This condition was not originally reported on the complaint.It is unknown how the ring was damaged.An internal corrective action has been created to investigate this condition.The catheter outer diameters were measured and the device was within specifications then per the reported event, an electrical test was performed and catheter passed.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.All the catheters are inspected for visual damages before packaging.On line inspections are in place to prevent this type of damage/defect from leaving the facility.The customer complaint was not confirmed.Management is notified of failure analysis results using monthly complaint trend reporting.For the damage ring, as previously stated, an internal corrective action has been created.

• Brand Name: LASSO¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING
• 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 3259 9; MX 32599
• Manufacturer Contact: jaime chavez ; 9098398483
• MDR Report Key: 4281290
• MDR Text Key: 5032405
• Report Number: 9673241-2014-00516
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K002333
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/17/2014

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: 03/31/2017
• Device Model Number: D-1220-38-S
• Device Catalogue Number: D7L1015RT
• Device Lot Number: 16108695L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/17/2014
• Initial Date FDA Received: 11/26/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2014
• 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