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 Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 10/13/2020

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 fibrillation (afib) procedure with a pentaray nav high-density mapping eco catheter and a spline fully separated issue occurred.It was reported that during the procedure, the distal portion of one of the pentaray nav high-density mapping eco catheter splines broke off in the left atrium (la) and got caught in the patient¿s mechanical mitral valve.The physician tried to retrieve it when in the inferior vena cava (ivc) and it drifted down toward the end femoral vein.The piece that was broken off was visualized using fluoroscopy and tracked to its final resting place in a small branch of the left iliac vein.The physician said that it should not cause harm there and that it was not worth having surgery to remove it.The physician did not report any abnormality while using the catheter.The patient did not develop any symptom.Prolonged hospitalization was not required.Per pentaray catheter instructions for use, the usage of this product is contraindicated in patient¿s with a mechanical valve.The spline fully separated was assessed as a mdr reportable issue.

Manufacturer Narrative

The bwi product analysis lab received, the device for evaluation on 3/22/2021.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: pc- (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a pentaray nav high-density mapping eco catheter and a spline fully separated issue occurred.It was reported that during the procedure, the distal portion of one of the pentaray nav high-density mapping eco catheter splines broke off in the left atrium (la) and got caught in the patient¿s mechanical mitral valve.The physician tried to retrieve it when in the inferior vena cava (ivc) and it drifted down toward the end femoral vein.The piece that was broken off was visualized using fluoroscopy and tracked to its final resting place in a small branch of the left iliac vein.The physician said that it should not cause harm there and that it was not worth having surgery to remove it.The physician did not report any abnormality while using the catheter.The patient did not develop any symptom.Prolonged hospitalization was not required.The device evaluation was completed on 4/15/2021.The product was returned to biosense webster for evaluation.Bwi conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the distal side of the spine "c" was found detached and internal components are exposed in the tip area on the pentaray nav eco catheter.All units are inspected prior leaving the facility as there are functional tests and inspections at control points based on the process flow diagram (pfd) per its part number to avoid this type of damage from leaving the facility.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint condition were identified.As part of bwi¿s quality process all devices are manufactured, inspected, and released to approved specifications.The root cause of spline detached could be related to use pentaray catheter in a patient with mechanical valve.The instructions for use contain the following statement: use of this catheter not appropriate for use in patients with prosthetic valves.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: pc-000785945.

• 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: 10820086
• MDR Text Key: 238136579
• Report Number: 2029046-2020-01662
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/11/2023
• Device Model Number: D128208
• Device Catalogue Number: D128208
• Device Lot Number: 30426532L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Date Manufacturer Received: 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NON BWI-ST. JUDE SL2 8.5FR SHEATH