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Model Number MI2355A |
Device Problems
Coagulation in Device or Device Ingredient (1096); Mechanical Problem (1384); Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/05/2024 |
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), a clot was noted on the end of the device after three attempts.The device was then flushed and further clots were noted coming out of the delivery system.The device was then unable to be recaptured completely into the cone.It was further noted that introducer exhibited valve damage and it was not flush. after looking at the dilator, it was noticed that a blue piece of introducer was on the dilator.A new introducer was used.The leadless ipg was attempted/not used and replaced. 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.The delivery system introducer distal seal leaks.The seal cap of the delivery system introducer was damaged.The analyst noted the introducer was returned with the dilator, seal cap and proximal seal separated from the introducer.The distal seal cut on the proximal side was cut out of alignment.The latches on the seal cap were damaged.There were no anomalies found with the latch holes for the seal cap on the seal valve body of the introducer.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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