MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) NAVISTAR® THERMOCOOL®; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number D-1197-18-S

Device Problems Crack (1135); Material Frayed (1262); Peeled/Delaminated (1454); Off-Label Use (1494); Inadequate Storage (1600)

Patient Problem No Patient Involvement (2645)

Event Date 10/02/2013

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The investigational analysis has been completed.Fifteen pieces were received with the pouch and plastic film sealed from the (b)(6) hospital.All devices presented, yellowing packaging, shaft peels and the lots were expired.Samples were sent to material evaluation.Results show that the yellowing condition is consistent with uv exposition.It was confirmed that the catheters show an evident degradation of the material which may be expected based on the storage condition reported above.The instructions for use (ifu) for storage showed that the catheter should be stored in a cool, dry, dark place.Storage temperature should be between 5 and 25ºc (41 and 77ºf).The device history record (dhr) was reviewed and no anomalies were found.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.The customer complaint has been verified.However the root cause is related to the storage conditions at the hospital.

Event Description

The biosense webster failure analysis lab received the device for evaluation on june 22, 2015 under 9673241-2013-00373 ((b)(4)).The returned catheter was received in a sealed pouch with the shaft cracked and peeling leaving the braid wires exposed.Small little pieces of shaft material were loose inside the sealed pouch.A supplemental was submitted on (b)(6), 2015 describing the returned catheter condition.However, further clarification was received on september 14, 2015 stating that this product received is not the product for (b)(4).It was found that this is an additional unopened product from the same account (aria (b)(4)).Therefore, this complaint under (b)(4) was created.This catheter was found in similar conditions as the unopened catheters stored in the same area as the catheters alleged in 9673241-2013-00346 ((b)(4)) and 9673241-2013-00373 ((b)(4)).These complaints were described that the blue shaft coating of the catheter, all the way to the base, started fraying off when they touched it.The account believed that the storage site was the root cause of the issue.The catheters were stored close to a window outside their boxes exposing the devices to the sunlight.

• Brand Name: NAVISTAR® THERMOCOOL®
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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: joaquin kurz ; 9497893837
• MDR Report Key: 5148252
• MDR Text Key: 28697420
• Report Number: 9673241-2015-00736
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/14/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2015
• Device Model Number: D-1197-18-S
• Device Catalogue Number: NI75TCJH
• Device Lot Number: 15740079M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/02/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2012
• 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