Model Number 1012455-12 |
Device Problems
Deflation Problem (1149); Difficult to Remove (1528); Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/22/2022 |
Event Type
Injury
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Manufacturer Narrative
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The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
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Event Description
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It was reported that the procedure was to treat a moderately calcified, mildly tortuous, 99% stenosed lesion in the left main (lm) artery.A 5x12mm nc trek balloon dilatation catheter (bdc) was advanced to the target lesion and inflated three times.The first inflation was to 10 atmospheres (atm), and the second and third inflations were to 16 atm.Negative was held for almost one minute however the balloon was very slow to deflate.The balloon would not retract into the guide liner.Resistance was felt during removal, and the shaft of the device separated into two pieces with approximately 20cm of the shaft inside the patient and the other part of the shaft hanging out of the guideliner.Additionally, the balloon separated into 2 pieces.A balloon was used to trap the separated portion of the shaft and the balloon in the gc and the bdc was pulled back into the radial sheath.The radial sheath was then removed.No additional information was provided.
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Manufacturer Narrative
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Visual inspections were performed on the returned device.The reported deflation issue and difficulty removing the device could not be replicated in a testing environment due to the condition of the returned device.It was noted that the outer member was separated distal to the guidewire exit notch and the inner member was separated distal to the guidewire exit notch, confirming the reported separation; however, the reported balloon separation was not confirmed.In this case, it is likely that the account perceived the balloon as separated since the other side of the bdc was reported as hanging out of the guideliner.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A conclusive cause for the reported deflation issue could not be determined; however, the reported difficulty removing the device, removal of foreign body and unexpected medical intervention appear to be related to circumstances of the procedure.The investigation determined the reported shaft separation and confirmed outer member separation distal to the guidewire exit notch and the inner member separation distal to the guidewire exit notch during return analysis appear to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.
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Search Alerts/Recalls
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