MAUDE Adverse Event Report: BIOSENSE WEBSTER INC EZ STEER THERMOCOOL NAVIGATION; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number	BNI75TCDFH
Medical Device Problem Codes	Entrapment of Device (1212); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The "injury" or "heart" clinical sign code will not pass transmission to the fda and is the preferred coding.However, "no clinical signs, symptoms or conditions" has been applied as a placeholder for the heart injury reported.Initial reporter phone: (b)(6).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30533502m number, and no internal action was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that a male patient underwent a ventricular tachycardia (vt) ablation procedure with a ez steer thermocool navigation.During the procedure the ablation catheter was hooked to the lead when it was about to be placed in the carotid sinus (cs) and the atrial lead was removed.This required surgical intervention to replace the lead.Atrial lead removed when the ablation catheter was hooked to the lead when it was about to be placed in the cs.No procedure was performed today, and ablation was continued.The lead will be re-implanted next wednesday.The physician commented that when an attempt was made to place the ablation catheter in the cs, it caught the lead and came out.The atrial lead of another company's product has come off.The ez steer thermocool navigation was entangled with the lead.This adverse event was discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse event: procedure.The intervention provided: the replacement of the lead is planned.Patient outcome of the adverse event: unchanged.A smartablate generator was used.The medical device entrapment is mdr-reportable as surgical intervention was required to resolve it.The event itself is also life threatening; it might result in permanent impairment of a body function or permanent damage to a body structure; or it required medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure.

• Brand Name: EZ STEER THERMOCOOL NAVIGATION
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• MDR Report Key: 12322604
• Report Number: 2029046-2021-01341
• Device Sequence Number: 4173207
• Product Code: OAD
• UDI-Device Identifier: 10846835003338
• UDI-Public: 10846835003338
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P030031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/21/2021

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: 04/21/2024
• Device Model Number: BNI75TCDFH
• Device Catalogue Number: BNI75TCDFH
• Device Lot Number: 30533502M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 08/16/2021
• 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: PENTARAY NAV; SMARTABLATE GENERATOR
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention