MEDTRONIC MEXICO S. DE R.L. DE CV BIO-MEDICUS STANDARD INSERTION KIT; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
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Model Number 96553 |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/02/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Reason for return was confirmed.Visual inspection on the peel pouch label shows the guidewire is to be 0.025 inches in diameter.The guidewire was measured using a micrometer to be 0.037 inches in diameter.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received information that during use, the customer reported the 96553 bio-medicus nextgen insertion kit, inner cylinder did not pass through the attached guidewire.The customer stated that the insertion kit is expected to contain two dilators but this product contained three.During the procedure, after inserting the guide wire into the patient's body, the blood vessel was dilated using three dilators, and when they tried to pass the cannula through the guide wire, the guide wire was thick.The cannula could not be inserted.Therefore, with the third dilator inserted, a new insertion kit was opened (96553) and only the guide wire was replaced, the cannula was inserted, and the procedure was continued.The customer stated that the pediatric insertion kit contained three dilators, and it is possible that they were mistakenly enclosed as an adult insertion kit at the time of manufacture.Additional information received indicates the procedure was extended by approximately 5-10 minutes and there was no damage to patient health.The issue was detected after inserting the guidewire into the patient body.The replacement device was restarted from the same puncture.
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Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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