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

Model Number D128211

Device Problems Device-Device Incompatibility (2919); Material Twisted/Bent (2981); Separation Problem (4043)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/28/2021

Event Type  malfunction  

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial flutter left (l-afl) ablation procedure with a pentaray nav high-density mapping eco catheter and a loose splines issue occurred.When inserting the pentaray nav high-density mapping eco catheter into the 8f sheath, there was resistance, and the catheter seemed to "jam up" in the sheath.The catheter was removed from the sheath, and it was noticed that the catheter splines became bent, and also seemed to be "loose." the catheter was replaced and the issue resolved.The procedure continued.No patient consequence was reported.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.The resistance with sheath issue was assessed as not mdr reportable.Interference or friction between devices is a known occurrence.If resistance is encountered, the system may be withdrawn as a unit.This is a common practice during procedures.Since the vast majority of ep procedures utilize multiple device exchanges, an increased potential for patient injury is remote.The splines bent issue 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 loose splines issue was assessed as a mdr reportable issue.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 29-aug-2021.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an atrial flutter left (l-afl) ablation procedure with a pentaray nav high-density mapping eco catheter.When inserting the pentaray nav high-density mapping eco catheter into the 8f sheath, there was resistance, and the catheter seemed to "jam up" in the sheath.The catheter was removed from the sheath, and it was noticed that the catheter splines became bent, and also seemed to be "loose." the catheter was replaced and the issue resolved.The procedure continued.No patient consequence was reported.The device evaluation was completed on 24-sep-2021.The product was returned to biosense webster for evaluation.Bwi conducted a visual inspection and outer diameter of polyurethane margins evaluation of the returned device.Visual analysis of the returned sample revealed splines deformed but no wires were exposed or damage on electrodes were found on the pentaray nav eco.Outer diameter of polyurethane margins were measured in accordance with bwi procedures.The catheter was working correctly and the device was found within specifications.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.As part of bwi¿s quality process all devices are manufactured, inspected, and released to approved specifications.The root cause of the damage on the splines cannot be determined since there is evidence that the device was manufactured in accordance with documented specification and procedures, it could be related to the handling; however, this cannot be conclusively determined.The device outer diameters are within the specifications; it should be noted that for the inability to introduce the catheter or advance through the sheath issues, the instructions for use contain the following information that should be considered: the pentaray¿ nav eco catheter is recommended for use with an 8f guiding sheath.Note: do not use the pentaray¿ nav eco catheter in conjunction with transseptal sheaths featuring side holes larger than 1.25 mm in diameter.Explanation of codes: investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the customer¿s reported ¿loose splines issue¿ and the ¿resistance with sheath issue¿.Investigation findings: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: tip (g04129) were selected as related to the customer¿s reported ¿spline bent issue¿.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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; 31 technology drive, suite 200; irvine CA 92618
• MDR Report Key: 12346414
• MDR Text Key: 267447412
• Report Number: 2029046-2021-01367
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/10/2024
• Device Model Number: D128211
• Device Catalogue Number: D128211
• Device Lot Number: 30564989L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2021
• Initial Date Manufacturer Received: 07/28/2021
• Initial Date FDA Received: 08/20/2021
• Supplement Dates Manufacturer Received: 08/29/2021; 09/24/2021
• Supplement Dates FDA Received: 08/31/2021; 10/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN BRAND 8F SHEATH.; UNKNOWN BRAND CATHETER.; UNKNOWN BRAND 8F SHEATH; UNKNOWN BRAND CATHETER