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

Catalog Number D128211

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/31/2017

Event Type  malfunction  

Manufacturer Narrative

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.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.(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a pentaray nav eco catheter and foreign material was discovered.When the catheter was removed from the patient after use, it was discovered that a semi-transparent filament like thread was found connected on one of the spines of the pentaray catheter.In addition, a film on the surface of the catheter was peeling off and described as rolling up.There were no lifted or sharp rings, or resistance with insertion or removal of the catheter.The procedure was completed without patient consequences.The issue with the foreign material attached to one of the pentaray spines is mdr reportable.If foreign material is found adhered to the catheter within the usable length during or after the procedure, it poses a risk to the patient such as embolism.The catheter surface peeling off is also reportable.If the catheter shaft is broken or damaged, then, the issue could result in ischemia or infarct.Additional intervention might be required to prevent serious injury or death.During the same procedure, additional non mdr reportable issues occurred.When the soundstar catheter was connected to the carto 3 system a magnetic sensor error occurred.The cable was reconnected and the eco cable was changed but the issue continued.The issue was resolved by changing the catheter to another one.This event is not mdr reportable because the incidence of magnetic sensor error is easy detectable by the user.The potential risk that it could cause or contribute to serious injury or death is remote.In addition, the temperature of the smarttouch sf catheter was not displayed.The cable was reconnected and changed but the issue continued.The issue was resolved by changing the catheter to another one.If the temperature does not display then ablation cannot be performed.The potential risk that it could cause or contribute to serious injury or death is remote.

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on (b)(6) 2017.The analysis has begun but is not completed at this time.On that date it was discovered that there was no material found on spine covers on the catheter.However, rings e18 and e20 were bent/smashed with no sharp edges.This finding is mdr reportable as it poses a potential risk to the patient.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.(b)(4).

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation procedure with a pentaray nav eco catheter and foreign material was discovered.The returned device was visually inspected and the ring #18 and #20 was found smashed with no sharp edges and no foreign material was observed.Then, the catheter outer diameter was measured and it was found within specifications.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 damage from leaving the facility.The customer complaint was confirmed.The root cause of the electrode damage cannot be determined.Based on available analysis finding results, the failure mode does not appear to be caused by any internal bwi processes, it could be related to the procedure.(b)(4).

• Brand Name: PENTARAY NAV
• Type of Device: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine 92618
• MDR Report Key: 6815055
• MDR Text Key: 83629438
• Report Number: 9673241-2017-01006
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012255
• UDI-Public: (01)10846835012255(11)170503(17)200430(10)17675700L
• 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: 07/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: D128211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2017
• Date Manufacturer Received: 07/31/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1