MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) HALO XP ELECTROPHYSIOLOGY CATHETER WITH AUTO ID; CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING

Model Number D-1160-43-S

Device Problems Knotted (1340); Difficult to Remove (1528); Failure to Read Input Signal (1581); Sticking (1597)

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

Event Date 06/07/2017

Event Type  malfunction  

Manufacturer Narrative

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.As such, the investigation will be closed.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.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.Concomitant products: terumo pinnacle 10cm 7fr short sheath, model and lot numbers unknown.Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a patient underwent a procedure for supraventricular tachycardia with a halo catheter where the catheter became knotted.During the procedure, the catheter became knotted, and was found to be difficult to remove from the patient's body.It appeared that the catheter was stuck in a partially deflected state.The physician was able to manipulate the hand controls, but the catheter would not respond to the inputs.A second catheter was used to assist in the removal of the knotted catheter.The procedure then continued with a new catheter, and the case was completed without patient consequence.There was no obvious damage to the catheter or electrodes noted upon withdrawal.The sheath in use was a terumo pinnacle 10cm short sheath (7fr).The issue with the deflection mechanism is not reportable.Since a catheter with this issue cannot deflect or relax completely, it cannot be used and must be replaced.The potential that this could cause or contribute to an adverse event is remote.However, the issue with the catheter becoming knotted is an mdr reportable event.Even if the integrity of the catheter is intact and no rings appear to be damaged or sharp, there is still a significant risk of damage to the patient's vascular structures.

Manufacturer Narrative

On (b)(4) 2017, 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.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

Manufacturer's reference number: (b)(4).It was reported that a patient underwent a procedure for supraventricular tachycardia with a halo catheter where the catheter became knotted.The returned device was visually inspected, and was found in good condition.Per the reported event, a deflection test was performed, which the catheter passed.The catheter outer diameter was measured, and was found within specification.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 cannot be confirmed.

• Brand Name: HALO XP ELECTROPHYSIOLOGY CATHETER WITH AUTO ID
• 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: 6681343
• MDR Text Key: 79065932
• Report Number: 9673241-2017-00548
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• PMA/PMN Number: K953663
• 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,Followup
• Report Date: 06/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: D-1160-43-S
• Device Catalogue Number: D7T20282CT
• Device Lot Number: 17628707L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2017
• 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