MAUDE Adverse Event Report: BIOSENSE WEBSTER INC PENTARAY NAV ECO 7FR, D, 2-6-2; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Catalog Number D128211

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2017

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.The device history record (dhr) for the lot number 17687129l has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a pentaray navigational eco catheter.It was reported that a foreign object was noted at the time of opening the pentaray navigational eco catheter package.The catheter was replaced and the issue was resolved.The response received confirmed that the foreign material was inside the package.There were no pictures available of the foreign material found.Therefore, it cannot be determined if the material was part of the packaging and was within the packaging specifications.The mdr determination was conservatively assessed as a reportable malfunction since there was a risk of contamination.

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 11/9/17.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).

Manufacturer Narrative

Investigation summary: it was reported that a patient underwent an atrial fibrillation procedure with a pentaray navigational eco catheter.It was reported that a foreign object was noted at the time of opening the pentaray navigational eco catheter package.The catheter was replaced and the issue was resolved.The response received confirmed that the foreign material was inside the package.There were no pictures available of the foreign material found.The device was visually inspected and it was found in normal conditions.The packaging was not received, investigation was unable to performed.A meeting with the manufacturing team was performed and they concluded that no investigation can be made.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.During manufacturing process, all the catheters are inspected for visual damages before packaging.On line inspections and functional tests are in place to prevent this type of failure from leaving the facility.The customer complaint was confirmed since a picture was provided by the customer; however the investigation could not be performed due to packaging was not returned.Manufacturer's reference number: (b)(4).

• Brand Name: PENTARAY NAV ECO 7FR, D, 2-6-2
• Type of Device: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 6888371
• MDR Text Key: 89367343
• Report Number: 9673241-2017-01085
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012255
• UDI-Public: (01)10846835012255(11)170531(17)200430(10)17687129L
• 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
• Report Date: 08/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: D128211
• Device Lot Number: 17687129L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2017
• Date Manufacturer Received: 08/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1