MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) LASSO® 2515 NAV ECO VARIABLE CATHETER; CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING

Model Number D-1343-01-S

Device Problems Material Frayed (1262); Physical Resistance (2578)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/24/2017

Event Type  malfunction  

Manufacturer Narrative

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) 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.(b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for atrial fibrillation with a lasso nav variable eco catheter where the catheter became frayed while inside the patient¿s body.During the procedure, while attempting to move the catheter from the left superior pulmonary vein to the left inferior pulmonary vein, the physician encountered resistance between the catheter and sheath.Slowly, the catheter was removed from the patient¿s body, and it was found to have frayed.The catheter was replaced, and the case continued without any patient consequences.Sheath information is unknown.No damage was observed at the distal end of the catheter upon withdrawal.The resistance between the catheter and sheath is a known occurrence, and in the event that it is encountered, the sheath and catheter can be withdrawn as a unit.This is a common practice during these types of procedures, and the vast majority of electrophysiology procedures utilize multiple device changes.The potential for patient injury is remote, and this is not an mdr reportable event.However, the fraying of the catheter exposes the patient to the internal catheter components, presenting a critical risk of thrombus.As a result, this event is mdr reportable.

Manufacturer Narrative

On 5/5/2017, biosense webster received a device for this complaint file with a lot number different than what was initially reported.Follow ups were performed, and on 6/14/2017, it was determined that the lot number of the returned device (17606753l) is the correct lot number.As a result, the lot/manufacturing/expiry date fields have been updated.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

Manufacturer's reference number: (b)(4).It was reported that a patient underwent an ablation procedure for atrial fibrillation with a lasso nav variable eco catheter where the catheter became frayed while inside the patient¿s body.The returned device was visually inspected, and one of the rings was found damaged.Foreign material was also present.Per these conditions, fourier transform infrared spectroscopy (ft-ir) analysis was performed.The foreign material was found to have a biological composition, presumably human tissue; the same absorption bands where observed when the foreign material was compared to the reference spectrum of human tissue.The catheter outer diameters were measured and found within specification.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.During the manufacturing process, all catheters are inspected for visual damage prior to packaging.On-line inspections and functional tests are in place to prevent catheters with this type of damage from leaving the facility.The customer complaint has been verified.The root cause of the ring damage cannot be determined, but the root cause of the foreign material could potentially be related to the procedure.However, this cannot be conclusively determined.

• Brand Name: LASSO® 2515 NAV ECO VARIABLE 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 32599 ; MX 32599
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6494534
• MDR Text Key: 73024650
• Report Number: 9673241-2017-00281
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K113213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/30/2017

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: 10/31/2019
• Device Model Number: D-1343-01-S
• Device Catalogue Number: D134301
• Device Lot Number: 17611407L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/28/2017
• Initial Date FDA Received: 04/14/2017
• Supplement Dates Manufacturer Received: Not provided; 03/28/2017
• Supplement Dates FDA Received: 06/23/2017; 07/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2016
• 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