MAUDE Adverse Event Report: BIOSENSE WEBSTER INC CARTO® 3 SYSTEM ECO INTERFACE CABLE; CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING

Catalog Number	D134401
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/08/2019
Type of Reportable Event	Malfunction
Additional 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.Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that the carto® 3 system eco interface cable sterile packaging was compromised as there was foreign material inside the packaging outside of specification.Inside the packaging of the carto® 3 system eco interface cable, there was a yellow marking.It was described as a yellow sticky substance or adhesive inside the package with the cable that compromised the sterile packaging.Additional information was received on the event on february 11, 2019.The carto® 3 system eco interface cable was never used on the patient or used in a live procedure.The issues of the foreign material inside the packaging which was outside of specification which compromised the sterile packaging, were assessed as reportable.The biosense webster, inc.Product analysis lab received the device for evaluation.During the visual inspection on february 25, 2019, it was noted that there was no yellow substance found inside of the packaging.However, there was yellow material found on the cable.The yellow material found on the cable remains a reportable issue.
Additional Manufacturer Narrative
On april 2, 2019, the biosense webster, inc.Product analysis lab noted that the fourier transform infra red analysis (ftir) analysis confirmed the sample had poly-ethylene characteristic which is consistent with adhesive material or glue.The adhesive glue was likely from manufacturing.This finding remained assessed as a reportable issue for the foreign material which was originally reported in the 3500a initial.The manufacturing record evaluation was provided on april 16, 2019.A manufacturing record evaluation was performed for the finished device serial number 30145414l and no internal action related to the reported complaint condition were identified.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
Investigation summary: it was reported that the carto® 3 system eco interface cable sterile packaging was compromised.Inside the packaging of the carto® 3 system eco interface cable, there was a yellow marking.It was described as a yellow sticky substance or adhesive inside the package with the cable.Additional information was received stating the cable was never used on the patient or used in a live procedure.The biosense webster, inc.Product analysis lab received the package and material and verified the foreign material on the cable.However, there was no foreign material found on the packaging.The sample was sent out for fourier transform infra red (ftir) analysis where it was confirmed the sample had poly-ethylene characteristic which is consistent with adhesive material or glue.The adhesive glue was likely from manufacturing.An investigation was performed at the biosense webster, inc.Packaging and it was verified that the adhesive found on the cable was not from the packaging process.The oem manufacturer was informed of the findings.It was confirmed that the yellowish material found on the cable was poly-ethylene which is consistent with adhesive.It is highly probable that the adhesive found was from manufacturing.The manufacturer (phillips medisize) initiated an internal action.A manufacturing record evaluation was performed for the finished device serial number: (b)(6) and no internal action related to the reported complaint condition were identified.Manufacturer's reference number: (b)(4).

• Brand Name: CARTO® 3 SYSTEM ECO INTERFACE CABLE
• 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: 8384694
• Report Number: 2029046-2019-02740
• Device Sequence Number: 11275433
• Product Code: DRF
• UDI-Device Identifier: 10846835009712
• UDI-Public: 10846835009712
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K113213
• 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,Followup,Followup
• Report Date (Section B): 02/08/2019

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: 10/28/2019
• Device Catalogue Number: D134401
• Device Lot Number: 30145414L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Initial Date Received by Manufacturer: 02/08/2019
• Supplement Date Received by Manufacturer: 04/02/2019; 10/14/2019
• Initial Report FDA Received Date: 03/02/2019
• Supplement Report FDA Received Date: 04/25/2019; 11/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1