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

Model Number D-1343-02-S

Device Problems Peeled/Delaminated (1454); Retraction Problem (1536); Material Protrusion/Extrusion (2979)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 04/22/2016

Event Type  malfunction  

Manufacturer Narrative

During further inspection on (b)(6) 2016, it was found the ring 9 and 10 were lifted up and wrinkled with a reddish brown material.The rings lifted up were also assessed as a reportable malfunction as they may cause damage to vascular endothelial linings during the withdrawal of the catheter and sheath.The awareness date for this issue is (b)(6) 2016.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 a atrial fibrillation (afib) procedure with a lasso navigational variable eco catheter.Initially it was reported that the lasso navigational variable eco catheter became entrapped in the tissue of the left atrium at the area of the ridge and left superior pulmonary vein.The physician was having difficulty retracting the catheter.With manipulation, the physician was able to retract the catheter and sheath together as one unit.A new transseptal puncture was performed and a new lasso navigational variable eco catheter was used to continue the procedure.The procedure was completed with no patient consequence.This issue was assessed as not reportable since the medical device was able to be removed without surgical intervention.Also, a transseptal puncture was a normal part of this type of procedure and in some cases two transseptal punctures occur in these types of procedures.The biosense webster failure analysis lab received the catheter for analysis.On (b)(6) 2016, it was found that the spine cover was wrinkled without exposed parts between rings 5 and 6.Also, the polyurethane (pu) of ring 8 was observed peeled.The spine cover wrinkled without exposed parts was assessed as not reportable as there was no exposure of internal components or any evidence that the integrity of the catheter had been compromised.Therefore, the potential that it could cause or contribute to a death, serious injury, or other significant adverse event was remote.The pu peeled was assessed as a reportable malfunction as the pu had a probability that it could be broken off or detached.The awareness date was reset to (b)(6) 2016.

Manufacturer Narrative

Additional information received on january 9, 2017 on clarification on the returned catheter condition.These conditions were noted after withdrawal of the catheter.The preface sheath 8f sheath was used.(b)(4).It was reported that a patient underwent a atrial fibrillation (afib) procedure with a lasso navigational variable eco catheter.Initially it was reported that the lasso navigational variable eco catheter became entrapped in the tissue of the left atrium at the area of the ridge and left superior pulmonary vein.The physician was having difficulty retracting the catheter.With manipulation, the physician was able to retract the catheter and sheath together as one unit.A new transseptal puncture was performed and a new lasso navigational variable eco catheter was used to continue the procedure.The procedure was completed with no patient consequence.The returned device was visually inspected and the spine cover was found wrinkled between rings 5 and 6.The polyurethane (pu) of ring 8 was observed peeled, and the ring 9 and 10 were found lifted up and wrinkled with a reddish brown material.Due the damage found, catheter outer diameters were measured and all were found within specifications.During manufacturing process on line inspections are in place to prevent this type of defect from leaving the facility.Then, a deflection and contraction tests were performed and the catheter passed deflection but contraction failed.An x-ray of the catheter loop was taken and could be observed the cables tangled inside the loop, this issue could be related with the external damaged found in the catheter.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 damages found could be related with the difficult to retract the catheter experienced during the procedure.Instructions for use (ifu) clearly indicates to avoid the usage of excessive force to advance or withdraw the catheter through the guiding sheath, when resistance is encountered.

• 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: 6212712
• MDR Text Key: 63822549
• Report Number: 9673241-2016-00917
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 04/25/2016

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: 12/31/2016
• Device Model Number: D-1343-02-S
• Device Catalogue Number: D134302
• Device Lot Number: 17420298L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/22/2016
• Initial Date FDA Received: 12/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2016
• 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