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

Model Number D-1290-02-S

Device Problems Hole In Material (1293); Dent in Material (2526); Wrinkled (2614); Device Contamination with Chemical or Other Material (2944); Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/20/2014

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a c3 navigational variable lasso catheter.A damaged electrode ring malfunction occurred.It was reported that the catheter´s electrodes 9 and 10 did not show signals at the beginning of the procedure.Exchanging to a navistar sf catheter resolved the issue.It was stated that the procedure was prolonged 360 minutes.Multiple attempts have been made to obtain clarification of the procedure delay.However, no further information has been made available.The procedure was completed successfully.There was no patient consequence.Upon visual inspection of the returned complaint catheter on (b)(4) 2014, bwi failure analysis lab noted the following: returned with printing on cam handle.Electrode ring #1 was dented.Electrode ring #7 was dented with the spine cover scratched in two places.Electrode ring #8 was dented, spine cover has small hole with flap and few scratches.Electrode ring #9 dented and spine cover has a hole with a flap.Electrode ring #10 was sharp, wrinkled with light blue material underneath the electrode ring proximal side.There was white foreign material on the distal side underneath electrode ring #19.Further information was requested in regards to the received catheter condition.Additional information provided stated that the catheter was not withdrawn from the patient with difficulty.There was no patient consequence.This catheter condition was not noted prior to using the catheter nor during withdrawal.It was also not noticed prior to sending the catheter to the (b)(4) lab.This condition was noticed during the procedure when the physician wanted to see the signals.The blue cordis 7fr sheath was used.

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.Lot number 15974779l was reported.The device history record (dhr) was reviewed.The dhr review verifies that the device was manufactured in accordance with documented specification and procedures.(b)(4).Event description continuation: this event was originally considered non-reportable, however, bwi became aware of the product returned condition of the sharp electrode rings with foreign material on (b)(4) 2014 and have reassessed the event as reportable.

Manufacturer Narrative

(b)(4) it was reported that the catheter´s electrodes 9 and 10 did not show signals at the beginning of the procedure.Exchanging to a navistar sf catheter resolved the issue.It was stated that the procedure was prolonged 360 minutes.Multiple attempts were made to obtain clarification of the procedure delay.However, no further information has been made available.The procedure was completed successfully.There was no patient consequence.Upon receipt, the catheter was visually inspected and there was some hand writing on the cam handle, which appeared to be written at some point during catheter return process.During manufacturing process this type of hand writing is not performed on the catheters.In addition, electrodes 1, 7, 8 and 9 were dented.Spine cover was also found damaged in some areas.Finally, electrode 10 was lifted with light blue material underneath it.Electrode is lifted proximal to distal which suggested that the catheter found friction during catheter withdrawing from sheath.In addition, the catheter ods were measured and catheter was within specifications.All these conditions were not originally reported on the complaint.Due to the quantity/mass size of the blue foreign material, the identification was not possible.Further investigation indicated that the customer used a 7fr sheath; however, the ifu recommends using an 8fr sheath for this type of catheter.Furthermore, all the catheters are inspected for visual damages before packaging.On line inspections are in place to prevent all the rings with damage from leaving the facility.Then per the reported event, the device was evaluated for electrical resistance and current leakage and it failed on electrode 10.Further examination revealed that the lead wire 10 was broken inside the tip section.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 reported customer complaint cannot be confirmed.For the damaged ring/foreign particles, an internal corrective action has been opened to investigate these issues.

Manufacturer Narrative

In the 3500a supplemental submitted on october 21, 2014, it was stated that, "the reported customer complaint cannot be confirmed." after further review, it should have stated, "the reported customer complaint has been verified." manufacturer's ref.No: (b)(4).

• Brand Name: LASSO 2515 NAV VARIABLE CATHETER
• Type of Device: ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE
• 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: jaime chavez ; 15715 arrow highway; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 4025312
• MDR Text Key: 4723246
• Report Number: 2029046-2014-00269
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K081258
• 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,Followup
• Report Date: 06/25/2014

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 Model Number: D-1290-02-S
• Device Catalogue Number: LN122515CT
• Device Lot Number: UNKNOWN_D-1290-02-S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/24/2014
• Initial Date FDA Received: 08/20/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/21/2014; 11/04/2014
• Was Device Evaluated by Manufacturer?: No
• 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