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

Model Number D-1290-01-S

Device Problems Knotted (1340); Difficult to Remove (1528)

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

Event Date 07/07/2016

Event Type  malfunction  

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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a c3 navigational variable lasso catheter.During the procedure, the physician used the catheter for mapping and monitoring signals of the pulmonary vein area.The physician almost finished the procedure and he was moving the catheter into the left atrium when the physician stated that the catheter knotted in the chamber.It was confirmed with fluoroscopy and echo.Although he had a hard time to remove the catheter out of sheath and finally from the body, the patient was stable throughout the procedure.We examined the catheter after removing it from the patient and it was literally knotted.The procedure was completed with no patient consequence.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.This issue of the knotted loop has been assessed as a reportable malfunction as it poses a risk of damage to the vascular structures of the patient.

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 9/27/2016.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.The biosense webster failure analysis lab received the catheter in the condition that was initially reported.In addition, after the knot was untied, it was noted that the plastic covering was cut approximately 2 cm from the tip and internal parts were exposed.There was also twisting of the plastic covering at the halo of the catheter.The returned catheter condition of the internal parts exposed was assessed as a reportable malfunction as the catheter integrity was not maintained and the internal components were exposed to the patient.(b)(4).

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrial fibrillation (afib) procedure with a c3 navigational variable lasso catheter.During the procedure, the physician used the catheter for mapping and monitoring signals of the pulmonary vein area.The physician almost finished the procedure and he was moving the catheter into the left atrium when the physician stated that the catheter knotted in the chamber.It was confirmed with fluoroscopy and echo.Although he had a hard time to remove the catheter out of sheath and finally from the body, the patient was stable throughout the procedure.They examined the catheter after removing it from the patient and it was literally knotted.The procedure was completed with no patient consequence.The catheter was visually inspected.The knot was observed in the loop; as well as the plastic covering was cut and twisted leaving internal parts exposed.Second visual inspection performed and the knot was removed to review the damages in the loop.Per these conditions, the catheter outer diameters were measured and it was found within specifications.An x-ray of the catheter loop was taken and no damage was observed, the internal components were found in good conditions.During manufacturing process, on line inspections are in place to prevent this type of damage/defect from leaving the facility.Deflection and contraction tests were performed and the 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.The customer complaint has been confirmed.However the root cause of the knot remains unknown.

• 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: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 5824801
• MDR Text Key: 51734466
• Report Number: 2029046-2016-00087
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K081258
• 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: 07/07/2016

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: 09/30/2018
• Device Model Number: D-1290-01-S
• Device Catalogue Number: LN222515CT
• Device Lot Number: UNKNOWN_D-1290-01-S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/07/2016
• Initial Date FDA Received: 07/26/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/25/2016; 11/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2015
• 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