Catalog Number 1013068-15 |
Device Problem
Deflation Problem (1149)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/13/2021 |
Event Type
malfunction
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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.The traveler device is currently not commercially available in the us; however, it is similar to a device sold in the us.
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Event Description
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It was reported that the procedure was to treat a proximal left main trunk - circumflex that was 90% stenosed.Pre-dilatation was done four times with an unspecified balloon at 6 atmospheres (atm), 10atm, 10atm, 10atm without issues.Then a 2.5x15mm non-abbott balloon was used and also dilated.Then a traveler rx balloon performed dilatations twice at 8 atm and 10 atm.However, the traveler balloon failed to deflate completely - only partially deflated.Negative pressure was applied several times for about 10 seconds but still failed to deflate remaining partially inflated.The device was removed partially deflated.A 3x12mm non-abbott balloon was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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Manufacturer Narrative
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Visual, dimensional and functional inspections were performed on the returned device.The reported deflation issue was not confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents and/or complaints from this lot.The investigation was unable to determine a conclusive cause for the reported deflation issue.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.Na.
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Event Description
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It was reported that the procedure was to treat a proximal left main trunk - circumflex that was 90% stenosed.Pre-dilatation was done four times with an unspecified balloon at 6atmospheres (atm), 10atm, 10atm, 10atm without issues.Then a 2.5x15mm non-abbott balloon was used and also dilated.Then a traveler rx performed dilatations twice at 8 atm and 10 atm.However, the traveler balloon failed to deflate completely - only partially deflated.Negative pressure was applied several times for about 10 seconds but still failed to deflate remaining partially inflated.The device was removed partially deflated.A 3x12mm non-abbott balloon was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.Subsequent to filing the initial report, the following additional information was received: a 4.5x6mm non-abbott balloon was used alongside with the traveler balloon for balloon angioplasty.Also, the traveler balloon was used for dilatations a total of six times throughout the procedure, not twice as initially reported.During removal, only the balloon dilatation catheter was removed from the anatomy.The device was not repositioned during inflations.There was no deflation issue after the first inflation (before inflating the second time).No additional information was provided.
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Search Alerts/Recalls
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