Model Number 1258T/86 |
Device Problem
Failure to Advance (2524)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/01/2020 |
Event Type
malfunction
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Manufacturer Narrative
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This product is registered as a combination product.The results/method and conclusion codes along with investigation results will be provided in the final report.
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Event Description
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It was reported that the patient presented for an implant procedure.During the procedure, the physician was having difficulty implanting the left ventricular (lv) lead due to the poor angle of the target vessel.The inner cavity of the lead entered the blood, and the guidewire could not be inserted to the tip.The lead was removed and replaced.The patient was stable.
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Manufacturer Narrative
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As received, a complete lead was returned in one piece.The guidewire that was used in the field was not returned with the lead.Visual and x-ray examination of the lead found the inner coil bunched up at the connector region and ptfe coating of guidewire was also noted in the connector pin.The cause of the reported event was isolated to the bunching of the inner coil at the connector region.
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Event Description
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Related manufacturer reference number: 2017865-2020-25090 it was reported that the patient presented for an implant procedure.During the procedure, the physician was having difficulty implanting the left ventricular (lv) lead due to the poor angle of the target vessel.The inner cavity of the lead entered the blood, and the guidewire could not be inserted to the tip.The lead was removed and replaced.The 2nd lead was unable to enter the target blood vessel after more than a hour of trying.The 2nd lead was also removed and replaced.The patient was stable.
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Manufacturer Narrative
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Correction: b5 and d11 - concomitant product information information missing.B5 and d11 have been updated.
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Search Alerts/Recalls
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