BIOSENSE WEBSTER, INC. (JUAREZ) NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
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Model Number D-1197-17-S |
Device Problems
Degraded (1153); Material Frayed (1262); Inadequate Storage (1600)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/23/2013 |
Event Type
malfunction
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Manufacturer Narrative
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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) the bwi failure analysis lab received the catheter on june 12, 2015.They noted that inside the pouch on the mounting card, it has small black material near the edge from the connector.Also, on the pouch label, it has a stain by ¿used by: 2016-01.¿ even though the investigation related to (b)(4) confirmed that the condition reported by the physician was related to exposure to ultraviolet light from the sun, this event is being reported because the bwi failure analysis lab received the device for evaluation and found inside the pouch on the mounting card it has small black material near the edge from the connector.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.The awareness date reflecting the catheter integrity issue is june 12, 2015.
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Event Description
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It was reported that this unopened navistar thermocool 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.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.However, since this catheter was from the same hospital and stored in the same storage area as 9673241-2013-00346 ((b)(4)).The investigation related to (b)(4) confirmed that the condition reported by the physician was related to exposure to ultraviolet light from the sun.It was confirmed that the devices were stored outside of their boxes facing the sunlight.The hospital was notified about the improper storage of the devices.The ifu states to store the catheters in a cool, dry place.Storage temperature should be between 5 and 25c (41 and 77 f).An ultraviolet conditioning testing was performed to try to reproduce the reported condition over some good catheter samples.The results demonstrated that the samples were discolored and the shafts were found cracked, exhibiting the same condition as the reported device.Therefore, the reported customer complaint has been verified.However, the evidence and the investigation showed that the catheter was manufactured accordingly and that external factors contributed to the shaft degradation.
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Manufacturer Narrative
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Manufacturer's ref.No: (b)(4).It was reported that unopened catheters were stored in the same area as the catheter alleged in (b)(4).Caller believes that the storage site is the root cause of the issue and would like to have these catheters analyzed.The catheters were stored close to a window outside their boxes exposing the devices to the sunlight.(b)(4) 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 base 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.
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Search Alerts/Recalls
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