BIOSENSE WEBSTER INC PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
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Model Number D128208 |
Device Problem
Contamination /Decontamination Problem (2895)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/28/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event is currently blank as the only information provided was the year of 2020.Therefore, additional clarification has been requested.The biosense webster, inc.Product analysis lab received the device for evaluation on june 19, 2020 and no visual damage or anomalies were observed.In addition, no small white part was observed on the device.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
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Event Description
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It was reported that a patient underwent a paroxysmal atrial fibrillation (afib) procedure with a pentaray nav high-density mapping eco catheter and there was foreign material on the usable length of the catheter.During the procedure, a small white part (similar to a small piece of paper) was present into the plastic part that keep together the splines of the pentaray nav high-density mapping eco catheter.There was no sheath.The piece was found before introducing the pentaray nav high-density mapping eco catheter into any sheath.The physician noticed this issue before inserting the catheter.The catheter was replaced, and the procedure was started and finished without any consequences for the patient.The foreign material on the usable length of the catheter was assessed as a reportable issue.
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Manufacturer Narrative
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Originally it was reported under the 3500a initial that ¿b3.Date of event is currently blank as the only information provided was the year of 2020.Therefore, additional clarification has been requested.¿ additional information was received on july 3, 2020 providing the event date.Therefore ¿b3.Date of event¿ has been populated.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
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Manufacturer Narrative
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On 7/16/2020, the product investigation was completed.Summary: it was reported that a patient underwent a paroxysmal atrial fibrillation (afib) procedure with a pentaray nav high-density mapping eco catheter and there was foreign material on the usable length of the catheter.During the procedure, a small white part (similar to a small piece of paper) was present into the plastic part that keep together the splines of the pentaray nav high-density mapping eco catheter.There was no sheath.The piece was found before introducing the pentaray nav high-density mapping eco catheter into any sheath.The physician noticed this issue before inserting the catheter.The catheter was replaced, and the procedure was started and finished without any consequences for the patient.The foreign material on the usable length of the catheter was assessed as a reportable issue.Device evaluation details: the device was visually inspected and no visual damage or anomalies observed, no small white part was observed on the device.A second closer inspection was performed and was found in good conditions, no small white part observed in the splines a manufacturing record evaluation was performed for the finished device 30361964l number, and no internal action related to the reported complaint was found during the review.The customer complaint cannot be confirmed.The catheter passed all specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
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