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

Model Number	D128210
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: visual inspection was performed and it was found that the rings on the spline appear deformed.Second closer inspection was performed and it was found that the spline was out of shape and ring was lifted.Then the electrical and outer diameter (od) tests were performed and failed due to the condition of the catheter.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint were identified.The customer complaint was confirmed.The root cause of the damage observed on the spline and electrode 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; however, this cannot be conclusively determined.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial flutter procedure with a pentaray nav high-density mapping eco catheter, and the biosense webster inc.Product analysis lab identified a spline ring lifted.It was reported that during a left sided atrial flutter ablation procedure, there was ecg noise from two of the pentaray nav high-density mapping eco catheter splines on the carto 3 system and ep recording systems.The issue began after the pentaray nav high-density mapping eco catheter was removed and then re-inserted it into the patient.The catheter was exchanged to resolve the noise, the procedure was continued successfully.Damaged/faulty pentaray nav high-density mapping eco catheter splines were the cause of the issue reported.The carto 3 system was operating per specifications.No patient consequences were reported.The noise issue was assessed as not reportable.The patient's heart rhythm was still visible to the operator when the signal noise or loss only affects only the body surface (bs) or intracardiac (ic) electrograms (but not both).With the information available, there was no indication that the electrodes were damaged or that internal catheter components were exposed.If there is a light bent or twist of the spline of the catheter; however, the integrity of the catheter was not compromised, then the potential risk that it could cause or contribute to a death or serious injury was remote.Therefore, the reported issue of the damaged/faulty pentaray nav high-density mapping eco catheter splines were assessed as not an mdr reportable issue.The biosense webster, inc.Product analysis lab received the device for evaluation and identified on june 1, 2020 that one of the spline rings appeared deformed and lifted.During a second closer inspection on june 16, 2020, this damage was confirmed.The returned condition of the spline rings being lifted was assessed as a mdr reportable issue.The awareness date for this reportable lab finding is june 1, 2020.

• Brand Name: PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER
• Common Device Name: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 10203197
• Report Number: 2029046-2020-00764
• Device Sequence Number: 2234147
• Product Code: MTD
• UDI-Device Identifier: 10846835012248
• UDI-Public: 10846835012248
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K123837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/20/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/13/2023
• Device Model Number: D128210
• Device Catalogue Number: D128210
• Device Lot Number: 30359037L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2020
• Initial Report FDA Received Date: 06/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1