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Model Number MI2355A |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/12/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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It was reported that during implant of a leadless implantable pulse generator (ipg), the hemostasis tool of the introducer sheath came off and protruded from the sheath. as a result, the patient's blood leaked from the sheath insertion port, so the physician blocked the insertion port with their thumb and prevented blood leakage.The sheath was then replaced with a new micra sheath, and the implantation procedure was completed successfully. no patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Product event summary: the introducer was returned and analyzed.Analysis indicated the distal seal of the delivery system introducer was torn.Blood was observed on the delivery system introducer distal seal.Blood was observed on the delivery system introducer proximal seal.Visual analysis of the catheter indicated damage during use.The analyst noted there was blood visible in the proximal and the distal seal.Destructive analysis was performed to complete visual inspection on the distal seal.A tear and skew were observed on the distal seal.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Search Alerts/Recalls
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