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 Bent (1059); Defective Component (2292); Physical Property Issue (3008)

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

Event Date 04/11/2017

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.Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a lasso® 2515 nav eco variable catheter and a deflection issue occurred.In the middle of the procedure, the curvature mechanism stopped working.Issue resolved by replacing the catheter.There was a case delay of 10 minutes.The procedure was completed with no patient consequence.This event was assessed as not mdr reportable because potential risk that it could cause or contribute to a serious injury or death is remote.The device was returned to biosense webster failure analysis lab and on june 21, 2017 it was discovered that ring #1 is squashed and bent down on the proximal side causing spine cover to fold over into the distal side of ring #2.Ring #2 was also squashed.The proximal side of ring # 2 was wrinkled.The proximal side of ring #1 was sharp, missing polyurethane (pu) margin, and the spine material was stressed due to the angle.Ring #2 distal has a small area where the ring was sharp.There was no difficulty withdrawing the catheter through the 8.5 french st.Jude medical sl0 swartz sheath that could have caused this damage.These findings were not noticed prior to use, upon withdrawal of the catheter or prior to sending the catheter in for analysis.The cumulative damage to ring #1 and ring #2 is mdr reportable.This damage has resulted in the exposure of sharp edges and squashed rings.If the electrodes of the catheter are dented, squashed, lifted or the pu border is damaged, then this can result in sharp edges and potential harm to the patient.The awareness date was reset to june 21, 2017, the date of the reportable damage was discovered.

Manufacturer Narrative

Manufacturer's ref no: (b)(4).It was reported that a patient underwent an atrial fibrillation procedure with a lasso® 2515 nav eco variable catheter and a deflection issue occurred.The returned device was visually inspected and it was found that the ring # 1 and ring #2 were squashed with sharp edges which is why this event is mdr reportable.Then per the event, a deflection and contraction test was performed and the catheter passed; the deflection mechanism was found working correctly, no issues were observed.Then the outer diameter was measured and it was found within specifications.For the condition observed, a scanning electron microscope (sem) testing was performed and the results showed evidence of mechanical damage on the surface of the spine cover and ring.It is possible that damage was generated with unknown object.No other anomalies were observed.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 manufacturing process, all the catheters are inspected for visual damages before packaging.On line inspections and functional tests are in place to prevent this type of damage from leaving the facility.The customer complaint cannot be confirmed.The root cause of the damage remains unknown.

• 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: 6704234
• MDR Text Key: 80041405
• Report Number: 9673241-2017-00568
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 04/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: D-1343-01-S
• Device Catalogue Number: D134301
• Device Lot Number: 17477484L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1