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 Dent in Material (2526); Material Twisted/Bent (2981); Scratched Material (3020)

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

Event Date 11/17/2015

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.(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a lasso catheter.Initially, the physician felt strangeness during handling when the lasso catheter was placed in the right pulmonary vein from the left pulmonary vein.The catheter was removed from the patient's body and was deflected.The connection part between the electrode ring and the shaft was twisted.However, there was no reported exposed components.The catheter was changed, but the same issue re-occurred after the right pulmonary vein isolation, created the cti and superior vena cava isolation.The issue was resolved by changing the catheter.The procedure was completed with no patient consequence.Additional information was received stating there was no difficulty in the insertion or the withdrawal of the catheter.No other information was able to be provided.Since there were no reported exposed components and with the information available, this event was assessed as not reportable.The product was received for analysis in the biosense webster failure analysis lab on december 18, 2015 and it was noted that the electrode ring #2 had a small area pushed down on the distal side causing it to be damaged and rough.The spine cover was twisted on the proximal side of electrode ring #10 to the transition with the tip lumen polyurethane (pu) margin.Since the electrode edge was rough, this condition was assessed as a reportable malfunction as it may cause damage to vascular endothelial linings during the withdrawal of the catheter.The awareness date was reset to december 18, 2015.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrial fibrillation (afib) procedure with a lasso catheter.The physician felt strangeness during handling when the lasso catheter was placed in the right pulmonary vein from the left pulmonary vein.The catheter was removed from the patient's body and was deflected.The connection part between the electrode ring and the shaft was twisted.However, there were no reported exposed components.The catheter was changed, but the same issue re-occurred after the right pulmonary vein isolation, created the cti and superior vena cava isolation.The issue was resolved by changing the catheter.The procedure was completed with no patient consequence.The returned device was visually inspected upon receipt and the spine cover was found twisted.Further investigation was made and it was noticed that the lasso loop was internally loose causing that lasso loop spins in its own axis.Continuing with the visual inspection, ring # 2 was found pushed down on distal side causing it to be damaged and rough.Further information received indicates that no resistance was noticed during the insertion or removal of the catheter.The catheter outer diameters were measured and it was found within specifications.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 verified.The root cause of the spinning loop and electrode damage cannot be determined.

• 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 32599 ; MX 32599
• Manufacturer Contact: joaquin kurz ; 9497893837
• MDR Report Key: 5370103
• MDR Text Key: 36473224
• Report Number: 9673241-2016-00030
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K002333
• 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: 11/17/2015

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: 05/31/2018
• Device Model Number: D-1220-38-S
• Device Catalogue Number: D7L1015RT
• Device Lot Number: 17250505L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/17/2015
• Initial Date FDA Received: 01/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2015
• 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