MAUDE Adverse Event Report: BIOSENSE WEBSTER INC PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Model Number D128211

Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907)

Patient Problems Foreign Body In Patient (2687); No Code Available (3191)

Event Date 01/27/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The product has not returned for analysis, however, a picture(s) were provided by the customer.Evaluation is still in progress.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference # (b)(4).

Event Description

It was reported that a patient underwent a right sided ischemic ventricular tachycardia ablation procedure with a pentaray nav high-density mapping eco catheter and a medical device entrapment occurred requiring surgical intervention.While mapping in the right ventricle (rv) with the pentaray nav high-density mapping eco catheter, the splines of the catheter became entrapped in the right ventricle (rv).The remainder of the procedure was aborted.There was no difficulty during the catheter insertion prior to the complication.The complication appeared to occur primarily at the level of the pentaray splines; this was made evident as the handle and shaft became mechanically separated from the splines as tension was applied by the primary physician when attempted to remove the catheter manually.Since manual removal was unsuccessful, the assistance of another physician was requested.A snare system was used in an attempt to remove the remaining parts of the pentaray nav high-density mapping eco catheter from the patient¿s body.However, the device sheared the splines of the catheter exposing the wires and causing some of the wires and spline components to detach from the pentaray.Some splines were unable to be retrieved by the physicians and are still present in patient¿s body.Upon catheter inspection, some rings appeared slightly disfigured, but not particularly lifted or sharp.All other catheters were removed from the patient¿s body without complication, pressure was held until hemostasis was obtained and patient was in stable condition as they left the lab.The patient was stable throughout the procedure, and no additional medical intervention was required.All other catheters and sheaths were removed from the patient¿s body without complication, pressure was held until hemostasis was obtained and patient was in stable condition as they left the lab.

Manufacturer Narrative

On february 14, 2020, additional information was received from the customer.It was reported that the patient was a 68-year-old male patient (139 lbs), therefore, section a2.Patient age at the time of event, a2.Age unit, a4.Weight of the patient, and a4.Weight of the patient have been populated.Initially it was reported that the patient underwent a right sided ischemic ventricular tachycardia ablation procedure, however, the patient underwent a right ventricle outflow tract/premature ventricular contraction (rvot/pvc) ablation procedure.It was also noted that as the physician was maneuvering the catheter to enter the right ventricle (rv) with the pentaray nav high-density mapping eco catheter, just getting below the level of the tricuspid calve, the catheter became caught in place.The splines appeared to be straight and forward without any movement.The physician called for another electrophysiologist to assist.The physicians decided to remove the catheter, however, it broke in half.The valve appeared to be ok at that point.Since manual removal was unsuccessful, ct surgery was requested.A snare system was introduced through a sheath in the femoral vein in attempt to remove the remaining parts of the catheter from the patient¿s body, however, the flower tip was snared.The device sheared the splines of the catheter exposing the wires and causing some of the wires and spline components to detach from the catheter.Some electrodes/spline covers were embedded and were unable to be retrieved by the physicians and are still present in the patient¿s body and the wiring was stripped.The patient reportedly followed up on february 10, 2020, and still did not have any clinical concerns.The physician used an sr0 sheath in the procedure which is a long sheath but fixed curve and not deflectable, which got the catheter to the point of the inferior vena cava/right atrium (ivc/ra) junction but not past the valve.The physician communicated he did not feel the event occurred due to a product malfunction.Confirmation was received that the patient did not have a mechanical valve.The biosense webster, inc.Representative was not aware of any scheduled intervention to remove the remaining pieces from the patient¿s body.Patient was reported to be fully recovered with no residual effects.Extended hospitalization was not required, patient stay overnight for observation and was discharged the following day.On february 22, 2020, the biosense webster, inc.Product analysis lab received the device for evaluation and upon initial visual inspection, it was noted that the spline part of the catheter was pulled apart from the rest of the 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference # (b)(4).

Manufacturer Narrative

Investigation summary = it was reported that a patient underwent a right sided ischemic ventricular tachycardia ablation procedure with a pentaray nav high-density mapping eco catheter and a medical device entrapment occurred requiring surgical intervention.While mapping in the right ventricle (rv) with the pentaray nav high-density mapping eco catheter, the splines of the catheter became entrapped in the right ventricle (rv).The remainder of the procedure was aborted.There was no difficulty during the catheter insertion prior to the complication.The complication appeared to occur primarily at the level of the pentaray splines; this was made evident as the handle and shaft became mechanically separated from the splines as tension was applied by the primary physician when attempted to remove the catheter manually.Since manual removal was unsuccessful, the assistance of another physician was requested.A snare system was used in an attempt to remove the remaining parts of the pentaray nav high-density mapping eco catheter from the patient¿s body.However, the device sheared the splines of the catheter exposing the wires and causing some of the wires and spline components to detach from the pentaray.Some splines were unable to be retrieved by the physicians and are still present in patient¿s body.Upon catheter inspection, some rings appeared slightly disfigured, but not particularly lifted or sharp.All other catheters were removed from the patient¿s body without complication, pressure was held until hemostasis was obtained and patient was in stable condition as they left the lab.The device was visually inspected, and the spline part of the catheter is pulled apart from the rest of the shaft.A second closer inspection was performed, and spines were found detached from the tip.A crack was inspected, and polyurethane (pu) was found in the peek housing transition crack.The device history record (dhr) for the lot number 30231231l has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.The customer complaint has been confirmed.The root cause of peek housing detachment and spines reported by the customer cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specification and procedures, it is related at the handling of the device during the procedure.According to pictures provided by customer, the pentaray nav high-density mapping eco catheter tip was observed to be detached from the shaft with exposed wires, splines and electrodes were observed damaged.Manufacturer's reference # (b)(4).

• Brand Name: PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER
• Type of Device: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 9709069
• MDR Text Key: 192426483
• Report Number: 2029046-2020-00233
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012255
• UDI-Public: 10846835012255
• Combination Product (y/n): N
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/02/2022
• Device Model Number: D128211
• Device Catalogue Number: D128211
• Device Lot Number: 30231231L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2020
• Date Manufacturer Received: 03/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BI DIR 7FR DEF CS,D-F,12 PIN; FIX,5F,4P,HIS,5MM,12PN-DR,115; SOUNDSTAR ECO GE 8F CATHETER; ST. JUDE MEDICAL FAST CATH SR0, 8.5F SHEATH; THMCL SMTCH SF BID, TC, D-F
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 63