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 Problems Bent (1059); Wrinkled (2614); Positioning Problem (3009); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2015

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 procedure with a lasso® 2515 nav eco variable catheter and a bent tip and deflection issue occurred.Before the catheter was entered into the patient's body, it was noticed that the tip of the catheter was bent.The catheter was inserted into the patient's body and the catheter would not deflect.The catheter was replaced and the case resumed.The procedure was completed with no patient consequence.This event was originally assessed as not mdr reportable since the potential that these issues could cause or contribute to a death or serious injury, or other significant adverse event, is remote.The biosense webster failure analysis lab received the device for evaluation on november 5, 2015 and during visual inspections it was noticed that the lasso loop was bent between ring #1 and ring #2 and the spine cover was wrinkled and torn open exposing nitinol spine.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.This finding is reportable because there is a loss of the catheter integrity due to the tear and exposure of the spine.The awareness date for this record is november 5, 2015 because that is when the damage was discovered.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrial fibrillation procedure with a lasso® 2515 nav eco variable catheter and a bent tip and deflection issue occurred.The returned device was visually inspected upon receipt and lasso loop was found bent between ring #1 and ring #2 spine cover wrinkled and torn open exposing nitinol spine, which is why this complaint was reported to the fda.Further information was requested regarding the condition of the catheter; however it has not been available for bwi.The catheter outer diameters were measured and it was found within specifications.Catheter was introduced into an instructions for use (ifu) recommended sheath without resistance noted.Per the event reported, a deflection and contraction test was performed and catheter failed during contraction test.An x-ray of the damage area was taken and it was noticed that wire electrode #1 was broken as well as the contraction puller wire bar causing the contraction issue.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.However, the root cause of the catheter loop bent cannot be determined.The ifu states that catheter tip should not be introduced folded into the guiding sheath and excessive force should not be used 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 ; 9497893837
• MDR Report Key: 5255498
• MDR Text Key: 32485853
• Report Number: 9673241-2015-00872
• 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: 09/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: D-1343-01-S
• Device Catalogue Number: D134301
• Device Lot Number: 17243034L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2015
• 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