MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Catalog Number D128208

Device Problem Separation Problem (4043)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/19/2018

Event Type  malfunction  

Manufacturer Narrative

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.As such the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.The device history record (dhr) for the lot number 30040356l has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.Concomitant medical products: st.Jude medical 8.5 (b)(6) sl1 sheath.(b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for left atrial flutter with a pentaray nav high-density mapping eco catheter and a ¿broken tip¿ issue occurred.There were no patient consequences.During the procedure, while manipulating the pentaray catheter, the spines came in contact with the artificial valve and the distal tips of 2 spines were sheared off.This information was corroborated in the photos provided.There was no resistance or difficulty during catheter insertion or removal.Damage resulted in exposure of wires.It was noted that the catheter was not pre-shaped.Patient was noted to be in stable condition.Treatment plan is to be determined.

Manufacturer Narrative

On (b)(6)2018, additional information was received indicating the complaint device has been discarded, therefore, the product is no longer available for return.Manufacturer's ref # (b)(4).

• Brand Name: PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER
• Type of Device: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 7982725
• MDR Text Key: 126102318
• Report Number: 2029046-2018-02189
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012224
• UDI-Public: 10846835012224
• Combination Product (y/n): N
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2021
• Device Catalogue Number: D128208
• Device Lot Number: 30040356L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1