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 Material Frayed (1262); Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/18/2018

Event Type  malfunction  

Manufacturer Narrative

The bwi failure 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.The device history record (dhr) for the lot number 17771800l has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.(b)(4).

Event Description

It was reported that a patient underwent a procedure with a pentaray nav high-density mapping eco catheter.It was reported that a heavy noise occurred at the bi electrical potentials 5-6 suddenly.The patient interface unit socket was reconnected, the cable was changed, pin of the lab was reconnected but the issue continued.The issue was resolved by changing the pentaray nav high-density mapping eco catheter to another one.The procedure was completed without patient's consequence.This noise issue was assessed as not reportable as the risk to the patient was low.The biosense webster failure analysis lab received the catheter for evaluation and discovered on may 9, 2018 that there was a kink on spline c between electrodes 10 and 11, approximately 0.6 cm from the pu dome.Electrodes 9, 10, 11 and 12 on spline c appear flattened and have sharp edges protruding.The kink found on spline was assessed as not reportable.If there is a light bent or twist on the spline of the catheter, however the integrity of the catheter was as designed and there¿s no wires exposed, then the potential risk that it could cause or contribute to a death or serious injury was remote.The sharp edges observed on the electrodes 9, 10, 11 and 12 are assessed as reportable malfunction.The awareness date for the reportable malfunction is may 9, 2018.On may 25, 2018, there was an additional assessment via scanning electron microscope analysis showed evidence of mechanical damage, scratches and an opening on the surface of the electrode with a sharp edge.The opening on the surface of the electrode with a sharp edge was assessed as a reportable malfunction.The sharp edge was previously reported and is not considered a new finding; however, the opening observed on the electrode surface is a new finding.The awareness date for this new finding is may 25, 2018.

Manufacturer Narrative

Investigation summary: it was reported that a patient underwent a procedure with a pentaray nav high-density mapping eco catheter.It was reported that a heavy noise occurred at the bi electrical potentials 5-6 suddenly.The patient interface unit socket was reconnected, the cable was changed, pin of the lab was reconnected but the issue continued.The issue was resolved by changing the pentaray nav high-density mapping eco catheter to another one.The procedure was completed without patient's consequence.The device was visually inspected and the spine was found bent and several rings were damaged with sharp edges.Then, an electrical test was performed and the catheter failed, no electrical readings were observed on electrode # 11.A failure analysis was performed and the catheter was dissected on the tip area, the electrical wire was found broken causing the improper electrical signal.Then, the catheter outer diameter was measured and it was found within specification.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 and a sharp edge was found.It is possible that the damage was generated with an unknown object.No other anomalies were observed.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.During the manufacturing process, inspections and functional tests are in place to prevent this type of failure from leaving the facility.The customer complaint was confirmed.The root cause of the electrical wire breakage and the damage observed cannot be determined since there is evidence that the device was manufactured in accordance with documented specification and procedures.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: 7559141
• MDR Text Key: 109772333
• Report Number: 2029046-2018-01623
• 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
• Report Date: 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2020
• Device Catalogue Number: D128211
• Device Lot Number: 17771800L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2018
• Date Manufacturer Received: 05/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1