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

Model Number D-1160-37-S

Device Problem Sticking (1597)

Patient Problem Tissue Damage (2104)

Event Date 06/10/2016

Event Type  Injury  

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.The device history record (dhr) for the lot number 17195171l 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 flutter (afl) procedure with a halo catheter and required surgical intervention.The patient's medical history is unknown.During the procedure, while the surgeon was positioning the halo catheter over the tricuspid valve, the catheter got stuck in the valve in a node format.As soon as this issue occurred, the patient was immediately sent to cardiac surgery to remove the catheter.There was no further damage to the patient.The patient was reported to be in good condition at the time the complaint was reported.There is no information about the hospitalization.The physician did not provide a causality opinion for the cause of this adverse event.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.Since this adverse event required medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr reportable.

Manufacturer Narrative

Additional information was received on this event on june 28, 2016.The patient was a (b)(6) year old male.The patient had prior coronary artery bypass surgery 15 years ago.The diagnosis pre-procedure was isthmus dependent atrial flutter.The patient had extensive "right atrial net" or "chiari net, involving the inferior vena cava valves and the right atrium, observed by a transesophagic echo some minutes before the procedure.The patient did require extended hospitalization and fully recovered with no residual effects.The physician¿s opinion regarding the cause of this adverse event is that it might be a combination between an anatomic patient's variation (extensive right atrial net involving the inferior vena cava valves) with the tip pliability of the catheter material.At the moment the catheter entered the right atrium through the inferior vena cava and the right atrial net (chiari net), a catheter curve was made and it wrapped up inside the right atrium.At this moment another catheter curve was used to take it out, but at this point the catheter was broken and it did not respond the usual way.It got stuck at the tricuspid papillary muscles valve.This s was confirmed by a transesophagic echo image.In conclusion, there was no way to remove the catheter.Therefore, the eletrophysiology team called the cardiac surgeon to remove it by open heart surgery.(b)(4).

Manufacturer Narrative

Additional information was received on this event on (b)(6) 2016 clarifying the previous statement that the catheter was broken and it didn´t respond the usual way.It was clarified that there was no exposed part due to the breakage reported.The issue was described as a knot and it was stated that probably due to the knot, the breakage occurred and the catheter no longer worked as intended.(b)(4).

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 8/26/2016.The following returned catheter condition was noted.The tip lumen cut off section was returned coiled inside a syringe.The catheter was returned up inside a cloth with the cordis introducer still attached to it.Also light reddish, white thread like material was attached to the shaft.The coil was exposed approximately 28.4 cm from the proximal end of the shaft.From the cut area of the tip lumen to approximately 62.4cm there was some type of sticky material on the shaft with light reddish, white thread like material attached to shaft.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

Manufacturer's ref.No: (b)(4).It was reported that a (b)(6) male patient, underwent an atrial flutter (afl) procedure with a halo catheter and required surgical intervention.During the procedure, while the surgeon was positioning the halo catheter over the tricuspid valve, the catheter got stuck in the valve in a node format.At this moment another catheter curve was used to take it out, but at this point the catheter was broken as it did not respond the usual way.It got stuck at the tricuspid papillary muscles valve.This was confirmed by a transesophagic echo image.In conclusion, there was no way to remove the catheter.Therefore, the electrophysiology team called the cardiac surgeon to remove it by open heart surgery.There was no further damage to the patient.The patient was reported to be in good condition at the time the complaint was reported.The patient did require extended hospitalization and fully recovered with no residual effects.The physician¿s opinion regarding the cause of this adverse event is that it might be a combination between an anatomic patient's variation (extensive right atrial net involving the inferior vena cava valves) with the tip pliability of the catheter material.Upon receipt, the catheter was visually inspected and tip lumen was found cut off and coil was found exposed at the shaft area.Further information and images received indicates that catheter was not broken with exposed parts during the procedure but was observed in a knot shape.Physician indicates that this might have happened due to a combination of an anatomic patient's variation and the tip pliability of the catheter material.A fourier transform infrared spectroscopy (ft-ir) test was performed comparing the chemical composition of the reported complaint catheter tip versus a good known catheter tip and the results demonstrated that there were no differences between the two samples.A thermal stability-thermogravimetrical analysis (tga) was also performed to both samples and no signs of degradation were found on the complaint device.Catheter outer diameters were measured and were found within specifications.No damage was observed on the electrodes or any degradation on tip was found on the analytical results that might contribute to the reported complaint.Continuing with the visual inspection light reddish, white thread like material was observed attached to shaft.A ft-ir test was performed in order to identify the type of material observed; the results demonstrated that was primarily composed of aliphatic ester base material wish is produced to obtain material as polyethylene.The spectra obtained from reddish brown material showed that material has physiologic nature since ir bands of human tissue.The origin of the material observed as well as the physical exposure of the internal parts of the catheter might happened while pulling the catheter out during the open heart surgery; however this cannot be conclusively determined.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 regarding a knotted catheter and entrapment has been verified.Neither the analysis performed nor the dhr suggest that the root cause of the failure reported could be related to the manufacturing process.The instructions for use (ifu) indicates that careful catheter manipulation must be performed in order to avoid cardiac damage, perforation, or tamponade.

• Brand Name: HALO
• 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: 5754042
• MDR Text Key: 48305902
• Report Number: 9673241-2016-00405
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K002333
• 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,Followup,Followup
• Report Date: 06/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: D-1160-37-S
• Device Catalogue Number: D7T20P15RT
• Device Lot Number: 17195171L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/13/2016
• Initial Date FDA Received: 06/28/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 07/13/2016; 07/21/2016; 09/06/2016; 11/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2015
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 80