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

Model Number D-1282-08-S

Device Problems Difficult To Position (1467); Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/11/2015

Event Type  malfunction  

Event Description

It was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) procedure with a pentaray nav eco catheter, and the catheter stayed deflected towards the f curve during use of the patient.It would not return to its native position.It would only relax to 90 degrees.There was difficulty removing the catheter from the patient.The catheter was replaced and the procedure continued.There was no patient injury.There was no physical damage noticed on the catheter.The 8fr pinnacle 11 cm sheath was used.This event is being reported because the catheter stayed deflected towards the f curve and would not return to its native confirmation.

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) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.(b)(4).

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on april 10, 2015.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Manufacturer's ref.No: (b)(4).

Manufacturer Narrative

(b)(4) it was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) procedure with a pentaray nav eco catheter, and the catheter stayed deflected towards the f curve during use of the patient.It would not return to its native position.It would only relax to 90 degrees.There was difficulty removing the catheter from the patient.The catheter was replaced and the procedure continued.There was no patient injury.There was no physical damage noticed on the catheter.The 8fr pinnacle 11 cm sheath was used.The returned device was visually inspected upon receipt and it was found that the catheter tip was found semi deflected and the shaft was found bent at 7cm far from the shaft to tip transition.A pre-curve test was performed and was found within specifications.No resistance or tension was felt while returning the catheter to an undeflected position.A deflection test was performed and the catheter passed.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.The customer complaint has been verified.However the root cause remains unknown.

• Brand Name: PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER
• Type of Device: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 3259 9; MX 32599
• Manufacturer Contact: shahe garabedian ; 9098397362
• MDR Report Key: 4650182
• MDR Text Key: 21543975
• Report Number: 9673241-2015-00178
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Model Number: D-1282-08-S
• Device Catalogue Number: D128208
• Device Lot Number: 17171915L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2015
• 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