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

Model Number D128211

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/14/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.  picture was provided by the customer.Evaluation is still in progress.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent a procedure with a pentaray nav high-density mapping eco catheter, and there was foreign material on the usable length of the catheter.It was reported that during a pulmonary vein isolation (pvi) ablation procedure, right before the pentaray nav high-density mapping eco catheter was inserted into the cardiac cavity, it was noticed that there was a sticker-liked material between the catheter and the insertion tube.The foreign material was removed, and the catheter was inserted into the cardiac cavity.The procedure was continued without further issues and was subsequently completed without patient consequence.A picture of the foreign material observed was provided.The sticker-liked material was assessed as mdr reportable foreign material on the usable length of the catheter.

Manufacturer Narrative

The bwi product 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: i (b)(4).

Manufacturer Narrative

It was reported that a patient underwent a procedure with a pentaray nav high-density mapping eco catheter.It was reported that during a pulmonary vein isolation (pvi) ablation procedure, right before the pentaray nav high-density mapping eco catheter was inserted into the cardiac cavity, it was noticed that there was a sticker-liked material between the catheter and the insertion tube.The foreign material was removed, and the catheter was inserted into the cardiac cavity.The procedure was continued without further issues and was subsequently completed without patient consequence.An analysis was performed on the pictures that were provided by the customer.According to the pictures, only an unknown particle was observed on the pictures, based on the event description, it can be suggested that the particle belongs to the seal or to the insertion tube; however, this cannot be conclusively determined.The customer complaint was confirmed.The product analysis was performed as appropriate in order to find the root cause of the complaint.Device evaluation was completed on (b)(6) 2020.During the investigation of this complaint, the customer provided a picture of the reported foreign material however, when the device was received in the lab and visual inspection was performed, the material was not found.The root cause of the loss of the foreign material could be related to the decontamination process or when the device was shipped for analysis.For this reason, the appropriate test could not be performed.As part of the investigation, the device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the manufacture process was reviewed, and no materials were identified that could be related to the foreign material reported.According with the investigation results, the customer complaint was confirmed; however, the foreign material could not be related to the manufacture process since there is evidence that the device was manufactured in accordance with documented specification and procedures.It could be related to the preparation of the device during procedure; however, this cannot be conclusively determined.During an internal review on (b)(6) 2020 noted correction to 3500a follow-up #1.Therefore, populated the following fields d10.Device available for evaluation?, d 10.Date device returned to manufacturer and d 10.Is device returned to manufacturer?.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

The investigation summary was initially submitted under the 3500a follow-up #2.However, after additional review, further investigation was performed.Therefore, the following is an updated investigation summary which was completed 11/6/2020.It was reported that a patient underwent a procedure with a pentaray nav high-density mapping eco catheter.It was reported that during a pulmonary vein isolation (pvi) ablation procedure, right before the pentaray nav high-density mapping eco catheter was inserted into the cardiac cavity, it was noticed that there was a sticker-liked material between the catheter and the insertion tube.The foreign material was removed, and the catheter was inserted into the cardiac cavity.The procedure was continued without further issues and was subsequently completed without patient consequence.An analysis was performed on the pictures that were provided by the customer.According to the pictures, only an unknown particle was observed on the pictures, based on the event description, it can be suggested that the particle belongs to the seal or to the insertion tube; however, this cannot be conclusively determined.The customer complaint was confirmed.The product analysis was performed as appropriate in order to find the root cause of the complaint.Device evaluation was completed on 11/6/2020.During the investigation of this complaint, the customer provided a picture of the reported foreign material; however, when the device was received in the lab and visual inspection was performed, the material was not found.The root cause of the loss of the foreign material could be related to the decontamination process or when the device was shipped for analysis.For this reason, the appropriate test to identify the composition of the foreign material source cannot be performed.However, a manufacturing investigation was initiated to evaluate if this issue is related to the manufacturing process.After the evaluation of this complaint file, according to the preliminary review provided by japan and characteristics depicted in such investigation, the residual potentially could be generated as a result of the toe tag punching operation.Tag placement is part of an identification process which helps to track the devices throughout the whole manufacturing process.Upon the removal of such tag, if the residual punch dot was not properly removed from the toe tag it may get stuck in the insertion tube.As part of the investigation, the device history record (dhr) was reviewed and no anomalies were found related to this complaint.Although foreign material detected by the customer was not received along with the device for further analysis and confirmation of composition, complaint herein is likely related to the toe tag punching process.According with the investigation results and evidence, the customer complaint was confirmed.It is likely that the foreign material was introduced during the toe tag manufacturing process; however, as material composition could not be evaluated, 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 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: 10393970
• MDR Text Key: 202948120
• Report Number: 2029046-2020-01028
• 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,Followup,Followup
• Report Date: 07/14/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 03/22/2023
• Device Model Number: D128211
• Device Catalogue Number: D128211
• Device Lot Number: 30379354L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Initial Date Manufacturer Received: 07/14/2020
• Initial Date FDA Received: 08/11/2020
• Supplement Dates Manufacturer Received: 08/18/2020; 09/07/2020; 11/06/2020
• Supplement Dates FDA Received: 08/19/2020; 09/16/2020; 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1