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

Model Number D-1282-07-S

Device Problems Entrapment of Device (1212); Improper or Incorrect Procedure or Method (2017); Physical Resistance (2578); Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 05/22/2017

Event Type  Injury  

Manufacturer Narrative

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.Concomitant products: merit medical 8 french short sheath.(b)(4).

Event Description

It was reported that a male patient underwent an ablation procedure for ventricular tachycardia with a pentaray nav eco high-density mapping catheter and suffered a medical device entrapment requiring surgical intervention.Post-procedure, resistance was met while withdrawing the pentaray nav eco catheter.Physician continued to withdraw the catheter against resistance.Pentaray ¿head¿ detached and lodged in the merit medical short sheath positioned in the right groin vascular access site.Sheath with the pentaray ¿head¿ still lodged inside had twisted and telescoped in on itself.It was determined that the sheath could not be safely removed in this state.Interventional cardiologist attempted to snare the pentaray catheter from the sheath.Eventually, the sheath was sufficiently straightened and the sheath and pentaray ¿head¿ were removed as a unit.Pentaray ¿head¿ was intact, however damage resulted in wires and/or braid being exposed.No pentaray parts embolized into the patient¿s vasculature.At the time of complaint report, there was no hematoma and no visible injuries at the right groin access site.Patient was monitored.Prolonged hospitalization did not occur.Patient reported soreness at the right groin access site.Patient has since fully recovered.Physician¿s opinion regarding the cause of the adverse event is that catheter withdrawal attempts should have ceased once resistance was met.Since this 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.

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 08/22/2017.The analysis has begun but is not completed at this time.During visual inspection, it was discovered that pentaray tip lumen was detached approximately 5 cm from the transition with the shaft with broken internal parts exposed.The detachment was originally reported in the initial medwatch report.In addition, tape with dark reddish brown material was attached to luer hub connector of the catheter.Other section of lip lumen with the spines is bent approximately 3 mm from the proximal side of ring #22 with internal parts exposed in the cut area.Ring #22 is sharp on proximal side.This damage is mdr reportable because the sharpness of the rings may cause damage to vascular endothelial linings during the withdrawal of the catheter and sheath.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.(b)(4).

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).It was reported that a male patient underwent an ablation procedure for ventricular tachycardia with a pentaray nav eco high-density mapping catheter and suffered a medical device entrapment requiring surgical intervention.The returned device was visually inspected and pentaray tip lumen was found detached approximately 5 cm from the transition with the shaft with broken internal parts exposed.Other section of lip lumen with the spines is bent approximately 3 mm from the proximal side of ring #22 with internal parts exposed in the cut area.Ring #22 is sharp on proximal side.White sheath with blue cap was returned cut and wrinkled with smaller sheath or introducer inside it measured.038 6fr.Per the condition observed, the catheter outer diameter was measured and it was found within specifications.Per the condition observed a scanning electron microscope (sem) testing was performed and the results showed results showed evidence of elongation and ductile dimples at tip.Stretching and/or pulling could be related to these surface characteristics, however the exact cause of the separation could not be conclusively determined.Cutting as the root cause was discarded since the separation site did not present any characteristics typical of this failure mode.No other anomalies were observed.Then, an investigation was performed with the engineering team and the result was that merit short sheath was collapsed first and, then, extra force was applied to withdraw this possibly deflected pentaray catheter through the sheath and it can categorize as an atypical failure.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.During manufacturing process, all the catheters are inspected for visual damages before packaging.On line inspections and functional tests are in place to prevent this type of damage from leaving the facility.The customer complaint has been verified.The root cause of the tip detachment cannot be determined, it could be related to the procedure and the force applied when the catheter was withdrawn.Afterwards, per the physician¿s opinion that the fellow should not have pulled when he met resistance.Additionally, the instructions for use states that excessive force must not be applied to advance or withdraw the catheter through the guiding sheath when resistance is encountered.Based on available analysis finding results, the damage does not appear to be caused by any internal bwi processes since the device was manufactured in accordance with documented specification and procedures.

• 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 32599 ; MX 32599
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6639865
• MDR Text Key: 77536362
• Report Number: 9673241-2017-00472
• Device Sequence Number: 1
• Product Code: MTD
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/22/2017

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 Expiration Date: 10/31/2019
• Device Model Number: D-1282-07-S
• Device Catalogue Number: D128207
• Device Lot Number: 17619844L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/22/2017
• Initial Date FDA Received: 06/14/2017
• Supplement Dates Manufacturer Received: 05/22/2017; 05/22/2017
• Supplement Dates FDA Received: 09/07/2017; 10/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2016
• 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): Required Intervention