MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SF; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	BDI35DFRT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Complete Heart Block (2627); No Code Available (3191)
Date of Event	08/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information received stated that the customer is retaining the product.No device was received for analysis at the time of submission of the initial 3500a.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 17621498l has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.Concomitant product: webster catheter, product code: d728260rt, lot #: unknown.(b)(4).
Event or Problem Description
It was reported that a patient underwent a cavotricuspid isthmus (cti) ablation procedure for atrial flutter with a c3 ez steer thermocool sf non-navigational catheter and suffered a heart block av requiring surgical intervention (cardiac pacemaker insertion).During the procedure, after ablating the cti, a heart block occurred.A vvi pacemaker (ventricle paced, ventricle sensed, inhibited if beat is sensed) was implanted.Patient was reported to be in stable condition on post-procedure day 1.Patient did not require extended hospitalization as a result of the adverse event.Patient outcome is improved.Physician¿s opinion regarding the cause of the adverse event is that it was related to procedure and patient condition.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.

• Brand Name: THERMOCOOL SF
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 6843789
• Report Number: 9673241-2017-01036
• Device Sequence Number: 809589
• Product Code: LPB
• UDI-Device Identifier: 10846835002812
• UDI-Public: (01)10846835002812(11)161205(17)191130(10)17621498L
• Combination Product (Y/N): N
• PMA/510(K) Number: P030031/S025
• 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
• Report Date (Section B): 08/10/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: BDI35DFRT
• Device Catalogue Number: BDI35DFRT
• Device Lot Number: 17621498L
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/10/2017
• Initial Report FDA Received Date: 09/05/2017
• 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: Required Intervention