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

Model Number D-1282-11-S

Device Problems Bent (1059); Folded (2630); Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2015

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a pentaray navigational eco catheter and the bwi failure analysis lab noted the returned catheter condition that the ring was lifted and sharp.It was originally reported that the pentaray navigational eco catheter spines were bent.The catheter was replaced and the procedure was continued.The procedure was completed with no patient consequence.Upon request additional information was provided.The bend prolapsed a spine.The spine was folded back on itself and was not useful.No exposed wires.There was no difficulty in removing the catheter.This event was assessed as not reportable as the potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.The bwi failure analysis received the catheter and noted the returned catheter condition on april 30, 2015.The spine cover c was pulled away from the pu center of the nitinol flower and was bent down about 4mm from the proximal side of ring #12 and bent again about 2mm from the proximal end of ring #10.Ring #11 was lifted up and sharp on the distal side.Additional information was provided on the returned catheter condition.The 8.5 fr sl1 sheath was used.The spine cover pulled away from the pu center of the nitinol flower was assessed as not reportable as there was there was no exposure of internal components or any evidence that the integrity of the catheter had been compromised and the spines were fully attached.This event is being reported because the bwi failure analysis lab received the device for evaluation and found ring #11 was lifted up and sharp on the distal side.The awareness date for this record was (b)(6) 2015.

Manufacturer Narrative

The bwi failure 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.(b)(4).

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrial fibrillation (afib) procedure with a pentaray navigational eco catheter.The pentaray navigational eco catheter spines were bent.The catheter was replaced and the procedure was continued.The procedure was completed with no patient consequence.Upon receipt, the catheter was visually inspected and it was found that the spine cover c was pulled away from the polyurethane (pu) center of the nitinol flower and was bent down about 4mm from the proximal side of ring # 12 and bent again about 2mm from proximal end of ring #10.Ring #11 was lifted up and sharp on the distal side.During analysis it was found that there were signs of the pu in the spine cover bent, so the spine cover was initially adhered.Due to the ring damaged, a scanning electron microscope (sem) analysis was performed and results showed that the proximal electrode ring material presented clear evidence of scratched and abrasion marks.The distal electrode ring presented deformations bumps and scratches marks.Probably this deformation found on the distal electrode ring was induced due to a stuck event and after that the ring lifted up as observed.It is very likely that the unknown object which caused the mechanical damage on the proximal electrode ring could cause the damages and lifted up condition found on the distal electrode ring.No other issues were found.Outside diameters were 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, dhr review verifies that device was manufactured in accordance with documented specification and procedures.The customer complaint has been confirmed.However, it is unknown how the damage occurred on the spine cover c and the rings.

• Brand Name: PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER
• Type of Device: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer Contact: shahe garabedian ; 9098397362
• MDR Report Key: 4806274
• MDR Text Key: 5916566
• Report Number: 9673241-2015-00333
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Model Number: D-1282-11-S
• Device Catalogue Number: D128211
• Device Lot Number: 17085405L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1