Catalog Number D128211 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/28/2017 |
Event Type
malfunction
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Manufacturer Narrative
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No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.The device history record (dhr) for the lot number 17687129l has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.Manufacturer's ref.No: (b)(4).
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Event Description
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It was reported that a patient underwent an atrial fibrillation procedure with a pentaray navigational eco catheter.It was reported that a foreign object was noted at the time of opening the pentaray navigational eco catheter package.The catheter was replaced and the issue was resolved.The response received confirmed that the foreign material was inside the package.There were no pictures available of the foreign material found.Therefore, it cannot be determined if the material was part of the packaging and was within the packaging specifications.The mdr determination was conservatively assessed as a reportable malfunction since there was a risk of contamination.
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Manufacturer Narrative
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The bwi failure analysis lab received the device for evaluation on 11/9/17.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.Manufacturer's ref.No: (b)(4).
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Manufacturer Narrative
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Investigation summary: it was reported that a patient underwent an atrial fibrillation procedure with a pentaray navigational eco catheter.It was reported that a foreign object was noted at the time of opening the pentaray navigational eco catheter package.The catheter was replaced and the issue was resolved.The response received confirmed that the foreign material was inside the package.There were no pictures available of the foreign material found.The device was visually inspected and it was found in normal conditions.The packaging was not received, investigation was unable to performed.A meeting with the manufacturing team was performed and they concluded that no investigation can be made.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.During manufacturing process, all the catheters are inspected for visual damages before packaging.On line inspections and functional tests are in place to prevent this type of failure from leaving the facility.The customer complaint was confirmed since a picture was provided by the customer; however the investigation could not be performed due to packaging was not returned.Manufacturer's reference number: (b)(4).
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Search Alerts/Recalls
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