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

Model Number NS7TCDL174HS

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation details: the device evaluation has been completed.The device was inspected, and no damage was observed however, during the second inspection the peek housing transition was observed cracked with internal parts exposed.An electrical test was performed, and the catheter failed.No electrical readings were observed on the electrode #2.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint were identified.The customer complaint was confirmed.The root cause of the electrical wire breakage and the damage on the peek housing cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specification and procedures, it could be related to the manipulation of the device during the procedure, however, this cannot be conclusively determined.(b)(4).

Event Description

It was reported that a patient underwent an ablation procedure with a navistar¿ electrophysiology catheter for which biosense webster¿s product analysis lab identified the peek housing was cracked with internal parts exposure.It was initially reported by the customer that at the beginning of the procedure intermittent noise was encountered on unipolar mapping 1 and 2.They changed the catheter for another and the procedure continued.There were no patient consequences.The customer¿s reported issue of intermittent noise on the mapping channels is considered to be not reportable since the risk to the patient is low.On 2/19/2020, the complaint product was returned to biosense webster inc.¿s (bwi) product analysis lab (pal) for evaluation.Initial visual analysis observed there was no visual damage or anomalies.On 2/28/2020, during a second visual analysis it was found that the peek housing transition was cracked, with internal parts exposed.These findings were reviewed and assessed as mdr reportable since the integrity of the device was not maintained.This event was originally considered non-reportable, however, bwi became aware of a reportable malfunction through visual analysis on 2/28/2020 and reassessed this complaint as mdr reportable.

• Brand Name: NAVISTAR ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 9881497
• MDR Text Key: 200666192
• Report Number: 2029046-2020-00456
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835000597
• UDI-Public: 10846835000597
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P990025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/06/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 09/10/2022
• Device Model Number: NS7TCDL174HS
• Device Catalogue Number: NS7TCDL174HS
• Device Lot Number: 30288325M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2020
• Initial Date Manufacturer Received: 02/28/2020
• Initial Date FDA Received: 03/25/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2019
• 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