MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) NAVISTAR MAPPING/ ABLATION CATHETER; CATHETER, ELECTRODE RECORDING

Model Number D-1184-08-S

Device Problems Degraded (1153); Material Frayed (1262); Inadequate Storage (1600)

Patient Problem No Patient Involvement (2645)

Event Date 09/23/2013

Event Type  malfunction  

Manufacturer Narrative

We are working on udi information, once we get more information it will be submitted in the supplemental.(b)(4).The investigational analysis has been completed.Fifteen pieces were received with the pouch and plastic film sealed from the aria 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

It was reported that this unopened navistar catheter was stored in the same area as the catheter alleged under 9673241-2013-00346 ((b)(4)) where it was 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.Multiple attempts had been made to obtain the product for this complaint.However, the product had not been returned for investigation.Since there was no evidence that this catheter had any issue, this complaint was assessed as not reportable.The bwi failure analysis lab received the device for evaluation on june 12, 2015.During the analysis on august 10, 2015, it was confirmed that the catheters show an evident degradation of the material which may be expected based on the storage condition reported above.Therefore, this condition has been assessed as a reportable malfunction.The awareness date is august 10, 2015.

Manufacturer Narrative

(b)(4).

• Brand Name: NAVISTAR MAPPING/ ABLATION CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING
• 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 ; 15715 arrow highway; irwindale, CA 91706 ; 9098397362
• MDR Report Key: 5054441
• MDR Text Key: 25918330
• Report Number: 9673241-2015-00591
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990025
• 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: 09/23/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2014
• Device Model Number: D-1184-08-S
• Device Catalogue Number: NS7TFL174HS
• Device Lot Number: 15254677M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/23/2013
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/03/2011
• 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