Model Number 352506070E |
Device Problems
Entrapment of Device (1212); Peeled/Delaminated (1454)
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Patient Problem
Insufficient Information (4580)
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Event Date 01/03/2022 |
Event Type
malfunction
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Event Description
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He found thread after inserting filter and it gets tangled in the filter hook to move the position of the filter.It looks like the inner wall of the sheath peels off.He retrieved filter and used bard and finished procedure.He wants to receive the investigation report.
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Manufacturer Narrative
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The sample is indicated as available for return.As of the date of this report, the sample has not been returned.A follow-up report will be provided once the device has been received and reviewed.
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Manufacturer Narrative
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The sample is indicated as available for return.As of the date of this report, the sample has not been returned.A follow-up report will be provided once the device has been received and reviewed.
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Event Description
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He found thread after inserting filter and it gets tangled in the filter hook to move the position of the filter.It looks like the inner wall of the sheath peels off.He retrieved filter and used bard and finished procedure.He wants to receive the investigation report.
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Manufacturer Narrative
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The sample is indicated as returned.As of the date of this report, the sample has not been evaluated.A follow-up report will be provided once the device has been reviewed.
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Event Description
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He found thread after inserting filter and it gets tangled in the filter hook to move the position of the filter.It looks like the inner wall of the sheath peels off.He retrieved filter and used bard and finished procedure.He wants to receive the investigation report.
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Manufacturer Narrative
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A review of the dhr and inspection records was conducted, and no similar concerns were found.The quality engineer and the complaint analyst reviewed the sample returned from the customer.The customer returned the pusher wire and the delivery catheter sheath.Visual inspection confirmed approximately 35 cm of liner delaminated from the delivery catheter sheath.The coil was also found to be not fully assembled inside the delivery catheter sheath.Therefore, this complaint was confirmed.Capa c-2021-052 was initiated to address the sheath delamination issues and the capa will identify the specific causes and corrective actions taken.
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Event Description
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He found thread after inserting filter and it gets tangled in the filter hook to move the position of the filter.It looks like the inner wall of the sheath peels off.He retrieved filter and used bard and finished procedure.He wants to receive the investigation report.
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Search Alerts/Recalls
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