Catalog Number CQ7584 |
Device Problems
Deflation Problem (1149); Product Quality Problem (1506)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)
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Event Type
Injury
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Event Description
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It was reported that the pta balloon would not deflate after the first inflation.A needle was inserted through the skin to deflate the balloon.There was no retraction difficulty.There was no reported pt injury.
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Manufacturer Narrative
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The device history records were reviewed and there was nothing found to indicate there was a mfg related cause for this event.This lot met all release criteria.This is the only complaint reported to date for this lot number for this failure mode.The device was returned.The investigation is inconclusive for deflation issues as full functional testing could not be completed due to the condition in which the sample was returned (i.E.Balloon was punctured).The root cause could not be determined based upon available info.It is unk whether pt and/or procedural issues contributed to the event.
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Manufacturer Narrative
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The evaluation found the glue bullet was lodged within the catheter haft, partially blocking the inflation /deflation ports.Additionally, the glue bullet did not appear perpendicular to the polyamide surface, which may have contributed to it becoming lodged.The root cause for the deflation issues is related to the glue bullet becoming lodged within the catheter shaft, which led to the retraction issues.The root cause for the improperly formed glue bullet is manufacturing related.
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Manufacturer Narrative
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A medical intervention was required to deflate the pta balloon with a needle stick through the skin.There was no known impact or consequence to patient.After further clinical review of this event with bard's medical department, this event was reassessed and determined to be mdr reportable as a serious injury pursuant to 21 cfr part 803.Correction: the root cause for the deflation issues is related to the glue bullet becoming lodged within the catheter shaft, which did not lead to the retraction issues.
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Manufacturer Narrative
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To ensure compliance to 21 cfr 803.50 a retrospective review of this file was conducted to determine if good faith efforts were made to obtain the required information and/or an explanation of why any required information was not provided.Multiple follow up attempts were made with the facility to obtain any information pertaining to the patient, product, and/or procedural details (e.G.Date of the event, relevant test data, relevant history, lot #, catalog #, implant and/or explanted dates, and concomitant product(s) or therapy) that were not previously obtained during the initial investigation.The report source did not have any additional details to provide at this time.
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Search Alerts/Recalls
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