MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number 87035

Device Problems Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906)

Patient Problem No Code Available (3191)

Event Date 03/28/2019

Event Type  Injury  

Event Description

It was reported the catheter became entangled in the tricuspid valve.An intellamap orion mapping catheter and another manufacturer's sheath were selected for use during a procedure to treat right ventricular tachycardia (vt) / ventricular fibrillation (vf).There was nothing untoward with the procedure; however, it was reported that visualization of the catheter on the mapping system showed it "pulled back and twisted," after which the deployment was affected.The catheter would not fully open and then seemed stuck.Equally, the physician couldn't retract the catheter back into the sheath, even with significant force.The deployment mechanism no longer worked to release the catheter.The patient was sent to surgery that same day to have the catheter removed.The patient's chest was opened via the sternum.The surgeon visually inspected the catheter in situ and it was observed to be fully intact; no splines had detached prior to entanglement.The catheter was very tangled in the chordae tendineae.The valve apparatus was wrapped around and inside the catheter, such that the basket could not open or close.The surgeon attempted to use the deployment function to see if it would release the spline from the tissue, but the basket would not open.The splines were then cut to remove the catheter, and removal was completed successfully.There was no record of any fragments remaining in the patient.The patient was reported to be "fine" following surgical removal; however, the original indication of vt/vf remained.The procedure was going to be reattempted at a later date.The patient did not experience any symptoms or complications aside from the need for surgical removal.

Event Description

It was reported the catheter became entangled in the tricuspid valve.An intellamap orion mapping catheter and another manufacturer's sheath were selected for use during a procedure to treat right ventricular tachycardia (vt) / ventricular fibrillation (vf).There was nothing untoward with the procedure; however, it was reported that visualization of the catheter on the mapping system showed it "pulled back and twisted," after which the deployment was affected.The catheter would not fully open and then seemed stuck.Equally, the physician couldn't retract the catheter back into the sheath, even with significant force.The deployment mechanism no longer worked to release the catheter.The patient was sent to surgery that same day to have the catheter removed.The patient's chest was opened via the sternum.The surgeon visually inspected the catheter in situ and it was observed to be fully intact; no splines had detached prior to entanglement.The catheter was very tangled in the chordae tendineae.The valve apparatus was wrapped around and inside the catheter, such that the basket could not open or close.The surgeon attempted to use the deployment function to see if it would release the spline from the tissue, but the basket would not open.The splines were then cut to remove the catheter, and removal was completed successfully.There was no record of any fragments remaining in the patient.The patient was reported to be "fine" following surgical removal; however, the original indication of vt/vf remained.The procedure was going to be reattempted at a later date.The patient did not experience any symptoms or complications aside from the need for surgical removal.

Manufacturer Narrative

Device evaluated by manufacturer: the returned device was cut into three pieces: the distal array, proximal array/distal shaft, and the remainder of the device.The introducer was cut into 2 pieces: the distal shaft, and the remainder of the device.Seven of the eight splines in the distal array exhibited an angled cut, likely from the open-heart extraction surgery.Spline 8 however, was not cut in the field; it exhibited a flat termination edge, typical of the pre-assembled condition.The individual splines had varying amounts of bending; splines 1, 2 and 3 had the most significant deformations.The lengths of the spline segments were measured after observing visually missing segments of splines 6 and 7.The segments of both spline 6 and 7 detached from under the polyimide collar, which most likely occurred during the open-heart extraction procedure.The orion and sheath were soaked and flushed with de-ionized water for 10 minutes at 5 ml/min to locate the missing pieces of spline.The irrigated fluids were reviewed.Beyond dried bodily fluid residues, no additional device pieces were dislodged during the soaking and flushing.The distal segment of the trimmed sheath showed signs of significant interaction with the orion array splines; gouges and flaring near the opening were present.The orion and sheath were likely trimmed at the same time, separating the 2cm distal section of the sheath and the 3 cm section of the orion shaft/proximal array from the remainder of the working length.In addition, the shaft of the orion was kinked near the proximal access to the sheath.The handle deployment mechanism slides normally.The deployment shaft can move freely within the device.A video of the arrhythmia hdx mapping window during the entanglement was provided by the field.The orion was primarily in the fully deployed (open) or partially deployed state during the length of the video.Minor torquing of the orion was observed while the array was open.A revolution of approximately 270 degrees of the orion (over a span of approximately 5 seconds) was observed while the array was open.The device contains significant damage due to entanglement and surgical removal from the patient.Beyond the damage, no abnormal device malfunctions were observed to have contributed to the clinical complications.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.(b)(4).

• Brand Name: INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8550772
• MDR Text Key: 143105300
• Report Number: 2134265-2019-04379
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 08714729841968
• UDI-Public: 08714729841968
• Combination Product (y/n): N
• PMA/PMN Number: K143481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/10/2020
• Device Model Number: 87035
• Device Catalogue Number: 87035
• Device Lot Number: 0023168562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2019
• Initial Date Manufacturer Received: 03/28/2019
• Initial Date FDA Received: 04/25/2019
• Supplement Dates Manufacturer Received: 05/31/2019
• Supplement Dates FDA Received: 06/25/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention