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 Contamination /Decontamination Problem (2895); Sharp Edges (4013)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/11/2019

Event Type  malfunction  

Manufacturer Narrative

The biosense webster, inc.Product analysis lab received the device for evaluation.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.A manufacturing record evaluation was performed for the finished device 30131297l number, and no internal action was found during the review.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an unknown procedure with a pentaray nav high-density mapping eco catheter and the biosense webster, inc.Product analysis lab found lifted rings with an electrical wire exposed and foreign material.Initially, it was described that when mapping was going to be conducted by pentaray nav high-density mapping eco catheter, a signal noise occurred at the 17-18/19-20.Noise occurred on both the lab and the carto 3 system.The cable was changed but the issue continued.The issue was resolved by changing the catheter.Because of the fam - dx install machine, mapping was performed with the pentaray nav high-density mapping eco catheter only before ablation catheter connection; however, error 912 did not resolve.Therefore, the ablation catheter was connected and mapping was conducted by using the pentaray nav high-density mapping eco catheter.The procedure was successfully completed without patient consequence.The signal noise issue was assessed as not reportable as the risk to the patient was low.The error 912 was assessed as not reportable as the potential risk that it could cause or contribute to a death or serious deterioration in state of health was remote.The biosense webster, inc.Product analysis lab received the product on february 7, 2019.The initial visual inspection revealed that the spine was bent, ring 18 was squashed and lifted with white material under the ring.Ring 19 was also found to be squashed.Ring 20 was squashed and lifted with white and reddish material under the ring.The lifted rings with foreign material were assessed as reportable issues.The awareness date for these issues were february 7, 2019.After additional assessment on february 18, 2019, it was discovered that an electrical wire was exposed as the ring was lifted, foreign material was under the ring and reddish-brown material was also found.The foreign material remains reportable.Since the ring was lifted and the wire was exposed, the lifted ring with the wire exposed remains a reportable issue.In addition, a scanning electron microscope (sem) analysis was performed on february 26, 2019 and it showed evidence of mechanical damage on the surface of the ring with a lifted edge.The lifted edge remains a reportable issue.

Manufacturer Narrative

On february 21, 2019, the foreign material was sent to perform a fourier transform infra red analysis (ftir) in the analytical laboratory, to identify the chemical composition of the foreign material.The results revealed that the foreign material is primarily composed of acrylonitrile butadiene styrene- based material (abs).However, the source of origin remains unknown.The foreign material was reported in the 3500a initial report.This issue remains reportable.Manufacturer's reference # (b)(4).

Manufacturer Narrative

Investigation summary: it was reported that a patient underwent an unknown procedure with a pentaray nav high-density mapping eco catheter.It was described that when mapping was going to be conducted by pentaray nav high-density mapping eco catheter, a signal noise occurred at the 17-18/19-20.Noise occurred on both the lab and the carto 3 system.The cable was changed but the issue continued.The issue was resolved by changing the catheter.Because of the fam - dx install machine, mapping was performed with the pentaray nav high-density mapping eco catheter only before ablation catheter connection; however, error 912 did not resolve.Therefore, the ablation catheter was connected, and mapping was conducted by using the pentaray nav high-density mapping eco catheter.The procedure was successfully completed without patient consequence.The device was visually inspected, and one spline was found bent, rings 18 and 20 were found squashed and lifted, white material was observed under the rings, reddish material was also found, and ring 19 was found squashed.Then, electrical test was performed on the catheter and it was found within specifications.No electrical malfunction was observed.Then, the catheter outer diameter was measured, and it was found within specification.A fourier transform infrared spectroscopy test (ftir) was performed and the results showed that foreign material is primarily composed of acrylonitrile butadiene styrene- based material (abs).However, the source of origin remains unknown.Additionally, a scanning electron microscope (sem) testing was performed on the damaged area and the results showed evidence of mechanical damage on the surface of the ring with a lifted edge.It is possible that the damage was generated with an unknown object.No other anomalies were observed.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint were identified.The customer complaint cannot be confirmed.The root cause of the damage on the spline 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 within the sheath during the procedure, however, this cannot be conclusively determined.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: 8404871
• MDR Text Key: 141622621
• Report Number: 2029046-2019-02772
• 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: 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/10/2021
• Device Catalogue Number: D128211
• Device Lot Number: 30131297L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• Date Manufacturer Received: 04/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1