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 Entrapment of Device (1212)

Patient Problem Rupture (2208)

Event Date 03/01/2019

Event Type  Injury  

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.Manufacturing record evaluation cannot be conducted because no lot number was provided by the customer.(b)(6).(b)(4).

Event Description

It was reported that a patient underwent an ablation procedure with a pentaray nav high-density mapping eco catheter wherein a medical device entrapment and papillary muscle rupture with valve insufficiency issues occurred.During the procedure, when moving the pentaray nav high-density mapping eco catheter from the right atrium to the right ventricle, the pentaray nav high-density mapping eco catheter got stuck in the chordae of the tricuspid valve and it was impossible to move it.The pentaray nav high-density mapping eco catheter was removed with the help of echographists who pulled slowly to take it out of the patient¿s body.Upon removal, the catheter appeared slightly distorted, but it was not broken.It was also reported there was a minimal tricuspid leak (tricuspid regurgitation).There¿s no indication that any other medical/surgical intervention or extended hospitalization was required.The catheter was replaced to complete procedure.The procedure was delayed for 60 minutes.Multiple attempts have been made to obtain additional information about this event with no response.Should any new information be obtained it will be assessed and processed accordingly.

Manufacturer Narrative

On 04/11/2019, biosense webster inc.Received additional information about the event and patient.It was reported the patient is a male.The catheter was removed with the help of transesophageal echography to guide the removal of the catheter from the patient¿s body.The physician had to apply excessive manipulation and pull firmly to remove the catheter.Extended hospitalization was not required.Patient¿s outcome is improved.Physician is unsure about the causality of the event.Although previously reported that the pentaray appeared slightly distorted but it was not broken, it was later reported that the catheter had usual appearance.The lot # 30167976l was also provided and field d4.Lot has been populated.On 4/12/2019, a manufacturing record evaluation (mre) was performed for the finished device with lot # 30167976l, and no internal actions were found during the review.Along with mre, the manufactured date and expiration date have also been provided.Therefore, fields expiration date and device manufacture date have been populated.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: 8501216
• MDR Text Key: 141566533
• Report Number: 2029046-2019-02969
• 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: 03/20/2019

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: 01/16/2022
• Device Catalogue Number: D128208
• Device Lot Number: 30167976L
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/20/2019
• Initial Date FDA Received: 04/10/2019
• Supplement Dates Manufacturer Received: 04/11/2019
• Supplement Dates FDA Received: 05/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention