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

Catalog Number D128211

Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 10/23/2018

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.The device history record (dhr) for the lot number 30079157l has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.Concomitant product: 1.Lasso navigational eco catheter , us catalog #: d134301, lot #: 30106850l.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a pentaray nav high-density mapping eco catheter and a medical device entrapment occurred which the spline fully separated requiring surgical intervention.During the procedure, the pentaray nav high-density mapping eco catheter was inserted into the left atrium and mapping was conducted.There was no resistance or difficulty noted during insertion of the pentaray nav high-density mapping eco catheter.It was not known which sheath was used during the procedure.When the catheter was near the anterior wall, the spline was caught in the artificial mitral valve and could not be moved.When the catheter was removed from the patient¿s body, one spline was torn and missing.It was confirmed that the spline mobilized to the patient¿s leg.The detached spline could be collected intraoperatively by using x-ray, fluoroscopy and an unspecified catheter.The patient¿s condition was unchanged, and the procedure continued.There is no information about the hospitalization.The physician did not provide a causality opinion for the cause of this adverse event.It was also reported that when the pulmonary vein was checked with the lasso navigational eco catheter, the catheter could not be deflected as intended.The issue was resolved by changing the catheter to another one.The procedure was completed without further issues.This medical device entrapment and separated spline issues were assessed as reportable issues.In this case, additional surgical intervention was required to preclude permanent impairment of a body function or permanent damage to body structure; therefore, this event it is to be considered serious and mdr-reportable.The deflection issue on the lasso navigational eco catheter was assessed as not reportable as the catheter was unable to deflect.Therefore, the user was not be able to use the device and had to replace it.The potential risk that it could cause or contribute to a death or serious deterioration in state of health was remote.

Manufacturer Narrative

The biosense webster inc.Failure analysis lab received the device for evaluation on (b)(6)2018.The device was returned in the condition reported of a completely separated spline with wires exposed.This issue remains reportable.Populated concomitant medical products.Device available for evaluation?, concomitant medical products.Is device returned to manufacturer? and concomitant medical products.Date device returned to manufacturer.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

Investigation summary: it was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a pentaray nav high-density mapping eco catheter and a medical device entrapment occurred which the spline fully separated requiring surgical intervention.During the procedure, the pentaray nav high-density mapping eco catheter was inserted into the left atrium and mapping was conducted.There was no resistance or difficulty noted during insertion of the pentaray nav high-density mapping eco catheter.It was not known which sheath was used during the procedure.When the catheter was near the anterior wall, the spline was caught in the artificial mitral valve and could not be moved.When the catheter was removed from the patient¿s body, one spline was torn and missing.It was confirmed that the spline mobilized to the patient¿s leg.The detached spline could be collected intraoperatively by using x-ray, fluoroscopy and an unspecified catheter.The patient¿s condition was unchanged, and the procedure continued.There is no information about the hospitalization.The device was inspected and the spline was found detached from the device, it was returned separated in a bag.Then, magnetic sensor functionality was tested on carto and the catheter was not visualized correctly since the missing spline was not observed on the carto, but no errors were observed.Then, the electrical test was performed, and failed due to the damage observed.Then, irrigation test was performed and it was found within specifications, the catheter was irrigating correctly, no irrigation issues were observed.Then, deflection test was performed and it was found within specifications, the catheter was deflecting correctly.Then, the catheter outer diameter was measured and it was found within specification.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 failure from leaving the facility.The customer complaint was confirmed.The root cause of the detachment cannot be related to the catheter since there is evidence that the device was manufactured in accordance with documented specification and procedures.It could be related to the procedure since the instructions for use state that the catheter should not be used in patients with prosthetic valves due to concern that the device would be trapped within the valve apparatus.Manufacturer's reference number:(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: 8083038
• MDR Text Key: 127545950
• Report Number: 2029046-2018-02303
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012255
• UDI-Public: 10846835012255
• 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,Followup
• Report Date: 10/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/20/2021
• Device Catalogue Number: D128211
• Device Lot Number: 30079157L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2018
• Date Manufacturer Received: 01/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other