MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) LASSO; CATHETER, ELECTRODE RECORDING

Model Number D-1237-02-S

Device Problem Sticking (1597)

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

Event Date 11/25/2016

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.The device history record (dhr) for the lot number 17495956l has been reviewed and it was verified that device was manufactured in accordance with documented specifications and procedures.(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a lasso variable catheter.During the procedure, the lasso variable catheter loop could no longer be adjusted.It was stuck in a fully contracted position.There was no difficulty in turning or pushing the handle.There was no difficulty in removing the catheter.The sheath information is not known.The catheter was replaced and the issue was resolved.The procedure was continued without patient consequence.Since the loop was stuck in a contracted position, this event has been assessed as a reportable malfunction as the device can potentially be related to serious injury.

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 1/5/2017.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).

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrial fibrillation (afib) procedure with a lasso variable catheter.During the procedure, the lasso variable catheter loop could no longer be adjusted.It was stuck in a fully contracted position.There was no difficulty in turning or pushing the handle.There was no difficulty in removing the catheter.The sheath information is not known.The catheter was replaced and the issue was resolved.The procedure was continued without patient consequence.The catheter received was visually inspected and it was found in normal conditions, the loop was not found stuck.Then per the event, a 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.Customer complaint has not been confirmed; since the catheter was found within specifications.

• Brand Name: LASSO
• Type of Device: CATHETER, 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: 6207850
• MDR Text Key: 63624067
• Report Number: 9673241-2016-00893
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K031161
• 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: 11/30/2016

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: 05/31/2019
• Device Model Number: D-1237-02-S
• Device Catalogue Number: D7L102515RT
• Device Lot Number: 17495956L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/28/2016
• Initial Date FDA Received: 12/27/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/09/2017; 01/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2016
• 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