INTERVASCULAR SAS HEMASHIELD WOVEN; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
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Model Number M002000196270 |
Device Problem
Product Quality Problem (1506)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/09/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(10/3233) it was reported that the product is available for investigation, it should be returned to intervascular for examination.(3331/213) the device history records review concluded that there was no non-conformance/planned deviation in relation with the event reported.(4109/213) the review of historical data indicated that no other similar complaint was reported for the same sterilization lot number 19j18.(11) the investigation is still ongoing.A follow-up report will be sent upon completion of the investigation.
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Event Description
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It was reported to intervascular that the doctor of cardiovascular surgery pointed out that there was dirt on the fabric.The corresponding product was not used, and a spare fabric with the same part number was used for surgery.Defective product will be returned.The event occured before surgery and the surgery was not postponed.Complaint (b)(4).
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Event Description
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Complaint (b)(4).
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Manufacturer Narrative
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(10/213) the involved device was returned to intervascular for examination, a visual inspection was performed by the quality assurance (qa) manager, the qa supervisor and two quality control technicians.It was concluded that the product is conform.Please note that the stains reported correspond to collagen which is, by design, part of the product coating.It as a known phenomenon where collagen is translucent at the time of manufacturing and turns yellow over time.(67) the conducted investigation concludes that the product is conform to the specification.
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Search Alerts/Recalls
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