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

Model Number D128208

Device Problem Material Separation (1562)

Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)

Event Date 03/01/2020

Event Type  malfunction  

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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacture reference no: (b)(4).

Event Description

It was reported that a female patient underwent an ablation procedure with a pentaray nav high-density mapping eco catheter, and the tip fully separated.During mapping in patient with a mechanical mitral valve, a spline of the catheter got entrapped within the valve.When the catheter was removed, a piece of the distal part of the spline was detached.Physician was aware of the contraindication, specified in the instructions for use (ifu) and during the case.However, the physician decided to use this catheter anyway.Patient recovered and remained in hospital for 24 hours observation.Patient did not require any medical or surgical intervention.No ablation catheters were used.There was difficulty removing the catheter and when the catheter was finally removed, the staff realized that the wire inside the spline was without the plastic cover.There were no lifted or sharp rings.The silicon part of the spline tip stayed inside the body, and after checking the patient, it was demonstrated that the plastic tip was in a place with no risk for the patient.No adverse patient consequences were reported.Per the pentaray nav high-density mapping eco catheter ifu, the use of this device in patients with prosthetic valves was contraindicated.The observed medical device entrapment required no excessive manipulation.Therefore.Was assessed as not mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.The observed fully separated tip has been assessed as an mdr reportable malfunction.

Manufacturer Narrative

It was reported that a female patient underwent an ablation procedure with a pentaray nav high-density mapping eco catheter, and the tip fully separated.During mapping in patient with a mechanical mitral valve, a spline of the catheter got entrapped within the valve.The biosense webster inc.(bwi) product analysis lab received the device for evaluation.Upon initial inspection, the bwi pal found one of the splines severed and detached from the tip.The observed severed spline detached from the tip has been assessed as an mdr reportable malfunction as device integrity was compromised.The investigational analysis completed 4/16/2020.The device was inspected and was observed damaged with spine detached and wire exposed.A manufacturing record evaluation was performed for the finished device, and no internal actions were found during the review.The customer complaint was confirmed.However, the root cause of the spine detached 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 handling of the device during the procedure since the instructions for use state ¿do not use pentaray catheters in patients with prosthetic valves.In the initial, serious injury was erroneously indicated in h1.An mdr reportable malfunction occurred and there was no serious injury.Malfunction has been selected in the h1 section.Manufacture reference no: (b)(4).

Manufacturer Narrative

During an internal review on 6/18/2020 a correction was noted to the 3500a initial report.The lot number in the field of d4.Lot was omitted.Therefore, this field has been updated.In addition, in the 3500a follow-up #1 the h4.Device manufacture date and d4.Expiration date were omitted.Therefore, these fields have been updated.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.No: (b)(4).

Manufacturer Narrative

During an internal review on (b)(6)2020 , a correction was identified under the 3500a initial as the code of ¿device fragment in patient¿ was omitted.Therefore, updated h6.Patient codes to reflect this code.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: pc-000665301.

• 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: 9882653
• MDR Text Key: 191595218
• Report Number: 2029046-2020-00477
• 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,Followup,Followup
• Report Date: 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/06/2022
• Device Model Number: D128208
• Device Catalogue Number: D128208
• Device Lot Number: 30315828L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1