MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. LASSO¿ 2515 VARIABLE CIRCULAR MAPPING CATHETER; CATHETER, ELECTRODE RECORDING

Catalog Number D7L102515RT

Device Problem Sharp Edges (4013)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2019

Event Type  malfunction  

Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.A manufacturing record evaluation was performed for the finished device 30186794l number, and no internal action related to the complaint was found during the review.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure with a lasso¿ 2515 variable circular mapping catheter that had a electrode damage.It was reported that electrode 2 of the catheter showed a mechanical damage.The lasso¿ 2515 variable circular mapping catheter was replaced.There were no patient consequences reported.It was later clarified that electrode 2 seems to be pulled out a little.The issue of electrode damage has been assessed as an mdr reportable malfunction.

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure with a lasso¿ 2515 variable circular mapping catheter that had a electrode damage.It was reported that electrode 2 of the catheter showed a mechanical damage.The lasso¿ 2515 variable circular mapping catheter was replaced.There were no patient consequences reported.It was later clarified that electrode 2 seems to be pulled out a little.Device evaluation details: the device evaluation has been completed.The device was visually inspected and it was found damage first electrode and raised electrode with sharp points.A manufacturing record evaluation was performed and no internal actions related to the reported complaint were identified.The customer complaint has been confirmed.The root cause of the electrode damage 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.Manufacturer¿s ref # pc-(b)(4).

Manufacturer Narrative

On 9/4/2019, the complaint product was returned to biosense webster inc.¿s (bwi) product analysis lab (pal) for evaluation.Initial visual inspection found ¿the first electrode from tipis partially lifted.¿ this finding is consistent with the customer¿s reported event of ¿electrode damage¿ and therefore the finding continues to be mdr reportable.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Manufacturer¿s ref # (b)(4).

• Brand Name: LASSO¿ 2515 VARIABLE CIRCULAR MAPPING CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 8849147
• MDR Text Key: 152940383
• Report Number: 2029046-2019-03468
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835000306
• UDI-Public: 10846835000306
• Combination Product (y/n): N
• PMA/PMN Number: K031161
• 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: 07/11/2019

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: 02/20/2022
• Device Catalogue Number: D7L102515RT
• Device Lot Number: 30186794L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Initial Date Manufacturer Received: 07/12/2019
• Initial Date FDA Received: 07/31/2019
• Supplement Dates Manufacturer Received: 09/04/2019; 09/24/2019
• Supplement Dates FDA Received: 09/18/2019; 09/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1