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

Catalog Number D128208

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2018

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.The device history record (dhr) for the lot number 30126222l 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 a paroxysmal atrial fibrillation (afib) procedure with a pentaray nav high-density mapping eco catheter and foreign material was found on the usable length of the catheter.It was reported that during the procedure, the splines of the pentaray nav high-density mapping eco catheter would not spread out.When the catheter was pulled out from the sheath, there was a long nylon string coming out with it.The catheter was replaced.No patient consequence reported.Additional information was received on (b)(6) 2019, clarifying the event.This issue was not noticed before use.It was noticed at the tail end of the procedure after the pentaray nav high-density mapping eco catheter was reintroduced into the left atrium.There was difficulty maneuvering the catheter.The splines on the pentaray nav high-density mapping eco catheter would not spread out when it was in the left atrium.Thus, leading to the withdrawal of the catheter.The "string" like component which resembled nylon followed the pentaray nav high-density mapping eco catheter out of an abbott¿s 8.5f agilis sheath.The pentaray nav high-density mapping eco catheter was intact.The foreign material on the usable length of the catheter was assessed as a reportable issue.

Manufacturer Narrative

In the 3500a initial report, it was reported that there was foreign material on the usable length of the catheter.The biosense webster inc.Product analysis lab received the device for evaluation on (b)(6)2019 and noted during the first visual inspection that there was no physical damage.The splines looked fine.No long nylon was seen and the long nylon was not returned with the product.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.Populated device available for evaluation?, is device returned to manufacturer? and date device returned to manufacturer.Manufacturer's ref.No:(b)(4).

Manufacturer Narrative

Investigation summary: it was reported that a patient underwent a paroxysmal atrial fibrillation (afib) procedure with a pentaray nav high-density mapping eco catheter.It was reported that during the procedure, the splines of the pentaray nav high-density mapping eco catheter would not spread out when it was in the left atrium.When the catheter was pulled out from the sheath, there was a long nylon string coming out with it.There was difficulty maneuvering the catheter.The pentaray nav high-density mapping eco catheter was intact.The catheter was replaced.No patient consequence reported.The device was visually inspected and it was found in good conditions, the foreign material reported (long nylon) was not returned for analysis.Then, irrigation test was performed and it was found within specifications, the catheter was irrigating correctly, no irrigation issues were observed.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.The customer complaint cannot be confirmed since the foreign material was not observed.A picture of the material was provided by the customer and it could be related to the procedure and cannot be related to the product since there is evidence that the device was manufactured in accordance with documented specification and procedures.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: 8251590
• MDR Text Key: 133383176
• Report Number: 2029046-2019-02578
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012224
• UDI-Public: 10846835012224
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2021
• Device Catalogue Number: D128208
• Device Lot Number: 30126222L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2019
• Date Manufacturer Received: 02/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1