MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. WEBSTER ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING

Model Number	F5QF005CT
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A manufacturing record evaluation was performed for the finished device 30263169m number, and no internal actions related to the reported complaint condition were identified.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
Event or Problem Description
It was reported that a patient underwent cardiac ablation procedure for atrioventricular nodal reentrant tachycardia/wolff-parkinson-white (avrt/wpw) with a webster¿ electrophysiology catheter wherein the catheter formed a knot.Right ventricle (rv) catheter got entangled during catheter placement.The physician used a deflectable sheath to maneuver and untangle the rv catheter.There was no patient consequence and the procedure continued normally.Additional information received indicated there were no exposed internal components, sharp or lifted rings.No component detachment occurred.There was no resistance or difficulty during insertion or removal of the catheter before and after entanglement.No report of extended hospitalization.
Additional Manufacturer Narrative
It was reported that a patient underwent cardiac ablation procedure for atrioventricular nodal reentrant tachycardia/wolff-parkinson-white (avrt/wpw) with a webster¿ electrophysiology catheter wherein the catheter formed a knot.Right ventricle (rv) catheter got entangled during catheter placement.The physician used a deflectable sheath to maneuver and untangle the rv catheter.There was no patient consequence and the procedure continued normally.Device evaluation details: on (b)(6)2020, the complaint product was returned to biosense webster inc.¿s (bwi) product analysis lab (pal) for evaluation.The device was visually inspected and catheter was observed kinked and manipulated.Then, curve profile test was performed and it was found within specification.A manufacturing record evaluation (mre) was performed, and no internal action related to the reported complaint condition were identified.The customer complaint was confirmed, per evidence provided by the customer.The catheter passed curve specifications.The root cause of kink was that the catheter became entangled.The root cause of catheter got entangled could be related to an incorrect manipulation during the procedure.All units are inspected prior leaving the facility and mre verified that this complaint unit was in good condition.Additionally, the customer had also provided a photo of the reported issue to aid in the investigation.According to fluoro picture provided by customer, catheter was observed knotted.This condition may have been related by the handling of the device during the procedure, however, this cannot be conclusively determined.The customer complaint was confirmed based on the picture received.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

• Brand Name: WEBSTER ELECTROPHYSIOLOGY CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 10544365
• Report Number: 2029046-2020-01281
• Device Sequence Number: 3134351
• Product Code: DRF
• UDI-Device Identifier: 10846835007305
• UDI-Public: 10846835007305
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K892265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/15/2022
• Device Model Number: F5QF005CT
• Device Catalogue Number: F5QF005CT
• Device Lot Number: 30263169M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Initial Date Received by Manufacturer: 08/18/2020
• Supplement Date Received by Manufacturer: 09/23/2020
• Initial Report FDA Received Date: 09/16/2020
• Supplement Report FDA Received Date: 10/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN DEFLECTABLE SHEATH