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 Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2019

Event Type  malfunction  

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.A manufacturing record evaluation was performed for the finished device 30110332l number, and no non-conformances was found during the review.Manufacturer¿s ref # (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for ischemic ventricular tachycardia (isvt) procedure with a pentaray nav high-density mapping eco catheter wherein the pentaray nav high-density mapping eco catheter became stuck within the terumo pinnacle 9f sheath (non-bwi sheath).It was reported that when extracting the pentaray nav high-density mapping eco catheter, it became stuck in the terumo pinnacle 9f sheath (possibly a kinked sheath) and the pentaray nav high-density mapping eco catheter started stretching at the first transition.Extraction was halted, and the terumo pinnacle 9f sheath and pentaray nav high-density mapping eco catheter were removed together from the body.The terumo pinnacle 9f sheath literally looked like an accordion, kinked multiple times over.It is possible the physician caused the damage during initial access with the terumo pinnacle 9f sheath.When the pentaray nav high-density mapping eco catheter was inserted, it would have ¿extended¿ the sheath back to normal length, but when removing the pentaray nav high-density mapping eco catheter, it would prolapse again, causing the pentaray nav high-density mapping eco catheter to be unable to be removed.The procedure was almost over therefore the pentaray nav high-density mapping eco catheter was not replaced.It was also reported that the outer poly covering did expose some wiring but no bare wires were seen.The internal shielding was intact and the issue did not result in any sharp or missing spine pieces.There was no patient consequence.The customer's reported event was reviewed and assessed as not reportable since the device is able to be removed without surgical intervention and internal wires were reported to not be exposed.The potential risk that it could cause or contribute to a serious injury or death to the operator or patient is remote.On 1/28/2019, the pentaray nav high-density mapping eco catheter was returned to biosense webster inc.¿s (bwi) product analysis lab (pal) for evaluation.Initial visual analysis identified ¿exposed wires 3 inches from the tip.Bent ring 1 inch from the tip.¿ the finding has been reviewed and assessed as an mdr reportable malfunction since there is evidence that the integrity of the pentaray nav high-density mapping eco catheter is compromised.This event was originally considered non-reportable, however, bwi became aware of a reportable malfunction through visual analysis on 01/28/2019 and has reassessed this complaint as reportable.

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure for ischemic ventricular tachycardia (isvt) procedure with a pentaray nav high-density mapping eco catheter wherein the pentaray nav high-density mapping eco catheter became stuck within the terumo pinnacle 9f sheath (non-bwi sheath).The customer's reported event was reviewed and assessed as not reportable since the device is able to be removed without surgical intervention and internal wires were reported to not be exposed.The potential risk that it could cause or contribute to a serious injury or death to the operator or patient is remote.On 1/28/2019, the pentaray nav high-density mapping eco catheter was returned to biosense webster inc.¿s (bwi) product analysis lab (pal) for evaluation.Initial visual analysis identified ¿exposed wires 3 inches from the tip.Bent ring 1 inch from the tip.¿ the finding has been reviewed and assessed as an mdr reportable malfunction.Device evaluation details: the device was inspected and exposed wires and a bent ring were observed on the tip area.Then, the catheter outer diameter was measured and it was found within specification.A manufacturing record evaluation was performed and no non-conformances related to the reported complaint were identified.The customer complaint was confirmed.The root cause of the damage on the tip could be related to the handling of the catheter with the sheath.In addition, the ifu states that no excessive of force should be applied during the insertion and withdrawal of the catheter.There is evidence that the device was manufactured in accordance with documented specification and procedures and this damage cannot be trace to a manufacturing issue.Manufacturer¿s ref # (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: 8350769
• MDR Text Key: 140001822
• Report Number: 2029046-2019-02697
• 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
• Type of Report: Initial,Followup
• Report Date: 01/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2021
• Device Catalogue Number: D128211
• Device Lot Number: 30110332L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2019
• Date Manufacturer Received: 03/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1