Model Number N/A |
Device Problems
Difficult to Insert (1316); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/21/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Patient information: no provided.Implanted date: device was not implanted.Explanted date: device was not explanted.Initial reporter name and address: phone number: unknown.Initial reporter occupation: cardio lab manager.The actual device was not returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.
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Event Description
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The user facility reported that the wire involved was unable to go through the needle.The wire gets stuck and kinks.The patient was in stable condition and the procedure was successful.There was no patient injury or medical/surgical intervention required.
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Manufacturer Narrative
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This report is being submitted as follow up no.1 to provide a correction to section e1 and to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.Review of the device history record (dhr) showed there were no issues noted during the manufacture of the product that could have contributed to this complaint condition.The sample was not available for assessment.The complaint cannot be confirmed for guidewire and needle mobility issues because the sample was not returned for assessment.The exact root cause could not be determined.There is no indication that any manufacturing, design or quality system issues may have led to this event.Currently no action is recommended since device was within manufacturing and design specifications when it was released from terumo medical corporation control.
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Search Alerts/Recalls
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