MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (IRWINDALE) WEBSTER; CATHETER, ELECTRODE RECORDING

Model Number D-1079-236-S

Device Problems Pacing Problem (1439); Positioning Problem (3009)

Patient Problems Torsades-de-Pointes (2107); Ventricular Tachycardia (2132)

Event Date 02/04/2017

Event Type  Injury  

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.Since no lot number was provided, no device history record (dhr) review could be performed.(b)(4).

Event Description

It was reported that a patient underwent an ablation procedure with a webster 4 pole catheter and suffered ventricular tachycardia (vt) requiring cardioversion and cardiac pacemaker insertion.The webster 4 pole catheter was being used as a temporary pacemaker in a patient with torsades de pointes.It was noted that the catheter was not positioned optimally and was not pacing.The catheter remained in the patient¿s cardiac cavity for 3 days.Subsequently, the patient went into vt and required two cardioversions.A permanent pacemaker was implanted.Patient was reported to be in stable condition.There is no information regarding extended hospitalization or patient outcome.Physician did not provide a causality opinion.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.

• Brand Name: WEBSTER
• Type of Device: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6364526
• MDR Text Key: 68516369
• Report Number: 2029046-2017-00050
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• PMA/PMN Number: K892265
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/09/2017

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
• Device Operator: Health Professional
• Device Model Number: D-1079-236-S
• Device Catalogue Number: D6DR252RT
• Device Lot Number: UNKNOWN_D-1079-236-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/09/2017
• Initial Date FDA Received: 02/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention