MAUDE Adverse Event Report: BIOSENSE WEBSTER INC LASSO® NAV ECO VARIABLE CATHETER; CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING

Model Number	D134302
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.A manufacturing record evaluation was performed for the finished device 30122504l number, and no internal actions related to the complaint was found during the review.Manufacturer's reference # (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) paroxysmal ablation procedure with a lasso® nav eco variable catheter and foreign material was found inside the packaging.It was described that there was hair found inside the vacuum package.There was no patient consequence and no additional information was provided.The issue of foreign material within the packaging has been assessed as an mdr reportable malfunction.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.
Additional Manufacturer Narrative
On november 26, 2019, the biosense webster, inc.Product analysis lab received the device for evaluation, and it was reported that upon initial visual inspection, the device packaging was returned in an open condition and a hair was found in the packaging.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.On december 9, 2019, additional information was provided with a correction to the facility name.The facility name was initially reported as (b)(6) hospital.Therefore, initial reporter facility name has been populated with the correct facility name, (b)(6) hospital.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference # (b)(4).
Additional Manufacturer Narrative
Investigation summary : it was reported that a patient underwent an atrial fibrillation (afib) paroxysmal ablation procedure with a lasso® nav eco variable catheter and foreign material was found inside the packaging.It was described that there was hair found inside the vacuum package.The device packaging was returned, a hair was observed inside.For this condition, the manufacture team performed an investigation in order to find the root cause.The investigation results showed that this issue is related to the manufacture process.An awareness training was performed to the production associates in order to reduce this kind of issue.A manufacturing record evaluation was performed for the finished device 30122504l number, and no internal actions related to the complaint was found during the review.The customer complaint was confirmed.Based on available analysis results, the complaint appears to be caused by internal biosense webster, inc.Operations, specifically, the manufacturing process.However, an internal action has been opened to investigate this issue.Manufacturer's reference # (b)(4).

• Brand Name: LASSO® NAV ECO VARIABLE CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 9373242
• Report Number: 2029046-2019-03931
• Device Sequence Number: 16821558
• Product Code: DRF
• UDI-Device Identifier: 10846835009644
• UDI-Public: 10846835009644
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K113213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/06/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: D134302
• Device Catalogue Number: D134302
• Device Lot Number: 30122504L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2019
• Initial Date Received by Manufacturer: 11/06/2019
• Supplement Date Received by Manufacturer: 11/26/2019; 01/29/2020
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 12/19/2019; 02/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1