MAUDE Adverse Event Report: BIOSENSE WEBSTER INC HALO¿ XP ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING

Catalog Number	D7T20P15RT
Medical Device Problem Codes	Entrapment of Device (1212); Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/06/2018
Type of Reportable Event	Serious Injury
Additional 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.The device history record (dhr) for the lot number 30099055l has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.Concomitant products: 1.Non-biosense webster, inc.Product - st.Jude medical 7.5 fr short sheath 2.Non-biosense webster, inc.Product - st.Jude/abbott esi mapping system manufacturer's reference # (b)(4).
Event or Problem Description
It was reported that a (b)(6) female patient underwent an atrial fibrillation (afib) ablation procedure on which the halo¿ xp electrophysiology catheter became entrapped in the right atrium requiring surgical intervention to remove it.During the procedure, the halo¿ xp electrophysiology catheter was used for a st.Jude /abbot esi mapping and became knotted and got entangled in the right atrium (ra).The catheter could not be removed safety from the patient¿s body via the sheath.A surgical vein cutdown intervention was performed to remove the catheter from the patient¿s body.The patient complained about soreness in groin; therefore, it stayed an overnight for groin monitoring and will require a follow up 4 weeks after the procedure with vascular and 2-3 months follow up with the physician for possible re-evaluation of ablation treatment.Physician¿s opinion regarding the cause of the adverse event is that it occurred due to challenges during catheter placement which caused the catheter knotted in the sheath.There was no physical damage such as exposure of any internal catheter component, electrode sharp edges or component detachment.The sheath used during the procedure was a st.Jude medical 7.5 fr short sheath.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.The knotted catheter and the described medical device entrapment issue were assessed as reportable issues.
Additional Manufacturer Narrative
On january 28, 2019, additional information was received from the biosense webster, inc.Representative.It was originally reported that "during the procedure, the halo¿ xp electrophysiology catheter was used for a st.Jude /abbot esi mapping and became knotted and got entangled in the right atrium (ra).The catheter could not be removed safety from the patient¿s body via the sheath.A surgical vein cutdown intervention was performed to remove the catheter from the patient¿s body." however, it has been clarified with the biosense webster, inc.Representative that during the procedure, the halo¿ xp electrophysiology catheter was used for a st.Jude /abbot esi mapping.The catheter was advanced through the sheath and became knotted just after exiting the short sheath in the groin.The physician could not get it to enter the right atrium.The catheter was entangled in the vasculature of the femoral vessels.As the physician was trying to remove it, it would not enter back into the sheath.Manufacturer's reference # (b)(4).
Additional Manufacturer Narrative
Additional information was received on december 7, 2018 stating that the catheter was disposed of in surgery.Therefore, fields method codes, result codes, and conclusion codes have been updated.The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
A correction was noted on (b)(6)2018 as originally the awareness date for follow-up #1 was reported as (b)(6)2018.However, the correct date is (b)(6)2018.Therefore, updated the pma/510k.Date received by manufacturer field.Manufacturer¿s reference number: (b)(4).

• Brand Name: HALO¿ XP ELECTROPHYSIOLOGY CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 8113694
• Report Number: 2029046-2018-02337
• Device Sequence Number: 11185925
• Product Code: DRF
• UDI-Device Identifier: 10846835000351
• UDI-Public: 10846835000351
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K002333
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/07/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/02/2021
• Device Catalogue Number: D7T20P15RT
• Device Lot Number: 30099055L
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/07/2018
• Supplement Date Received by Manufacturer: 12/07/2018; 12/05/2018; 01/28/2019
• Initial Report FDA Received Date: 11/28/2018
• Supplement Report FDA Received Date: 12/19/2018; 12/20/2018; 02/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 88