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 Problem Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/20/2016

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.Concomitant products: st.Jude medical sl0 8fr sheath.(b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for atrial fibrillation with a lasso nav variable eco catheter where the catheter became stuck in the fully contracted position.Midway through the procedure, the catheter loop stopped expanding/contracting correctly.It was noted that while the catheter loop was stuck in a fully contracted position, the knob /piston was unable to be turned or pushed up and down.The catheter was removed from the patient without any difficulty, and the case continued with a new like catheter.No patient consequences were reported.This type of malfunction can potentially be related to a serious injury.As a result, this event is mdr reportable.

Manufacturer Narrative

Manufacturer's reference number: (b)(4).It was reported that a patient underwent an ablation procedure for atrial fibrillation with a lasso nav variable eco catheter where the catheter became stuck in the fully contracted position.The returned device was inspected and found in good condition.Per the reported event, deflection and contraction tests were performed.The catheter passed the deflection test, but failed the contraction test.The catheter did not get stuck, nor was any resistance noticed during the deflection and contraction tests.The catheter was then dissected, and the puller wire was found detached from the loop at the tip area, causing the catheter loop contraction failure.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 catheter failed the contraction test.However, the catheter did not get stuck during failure analysis.The root cause of the puller wire detachment at the tip area cannot be determined.Based on available analysis finding results, the failure mode does not appear to be caused by any internal bwi processes; contraction and deflection tests are performed during manufacturing process.The customer complaint regarding the catheter loop getting stuck cannot be confirmed.

• 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: 6034007
• MDR Text Key: 57925602
• Report Number: 9673241-2016-00700
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• PMA/PMN Number: K113213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/21/2016

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: 06/30/2016
• Device Model Number: D-1343-01-S
• Device Catalogue Number: D134301
• Device Lot Number: 17527195L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/21/2016
• Initial Date FDA Received: 10/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2016
• 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