BIOSENSE WEBSTER INC. PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
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Model Number D128208 |
Device Problems
Contamination /Decontamination Problem (2895); Sharp Edges (4013)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/27/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Device evaluation: the device evaluation has been completed.Initial visual inspection was performed, and a spline was found out of shape.A second, closer inspection was performed and it was found the spline is out of shape & foreign material under a lifted ring.The od test was performed and failed due the damage present on spline & ring.The catheter was sent to the laboratory for analysis of the foreign material.A fourier transform infrared spectroscopy test (ftir) was performed and the results showed that the foreign matter under ring is composed by polyurethane-base material and a second component barium sulfate (baso4); the source of origin remains unknown.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint were identified.The customer complaint was confirmed.The root cause of the damage observed on the spline, the electrode and foreign material cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specification and procedures, it could be related to the handling of the device during the procedure, however, this cannot be conclusively determined.The foreign material observed could be generated due to the manipulation of the catheter with the sheath since a damage electrode was observed.Manufacturer¿s ref # (b)(4).
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Event Description
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It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a pentaray nav high-density mapping eco catheter for which biosense webster¿s product analysis lab identified lifted electrode rings along with foreign material under the electrode rings.It was initially reported by the customer that upon inspection of the pentaray nav high-density mapping eco catheter, the physician noticed that there was a twist/bent on one of the splines of the catheter.The physician did not feel comfortable using the pentaray nav high-density mapping eco catheter and requested a replacement.The pentaray nav high-density mapping eco catheter was replaced and the procedure was continued.There were no patient consequences.Based on the information reported by the customer, the issue of twisted/bent spline was assessed as not mdr reportable since the potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.On 5/26/2020, the complaint product was returned to biosense webster inc.¿s (bwi) product analysis lab (pal) for evaluation.Initial visual inspection found that a spline is out of shape.This returned condition was assessed as not mdr reportable since the potential risk that it could cause or contribute to a serious injury or death is remote.On 6/9/2020, during a second visual inspection a spline was found out of shape & foreign material under a lifted ring.These findings of foreign material and lifted rings were both assessed as mdr reportable malfunctions.This event was originally considered non-reportable, however, bwi became aware of a reportable malfunction through visual analysis on 6/9/3030 and reassessed this complaint as mdr reportable.
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