Catalog Number 1012451-20 |
Device Problems
Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Intimal Dissection (1333)
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Event Date 01/21/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4) during processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant medical products: guide wire: fielder, balance middleweight, sion blue, guide catheter : al1 6f, 7f; ebu 3.5 7f, other: finecross 150 microcatheter; guideliner.(b)(4) the customer reported the device was discarded.Investigation is not yet complete.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 pre-dilatation was performed in the mid right coronary artery (rca) with a 2.5 x 20 mm nc trek balloon at 12 atmospheres (atm).Additional pre-dilatation was done in the mid rca to proximal rca with a 3.5 x 20 mm nc trek balloon at 12 to 22 atm, 7 times.Follow-up angiography revealed significant residual stenosis and type 'a' dissection from mid to proximal rca.A 3.5 x 28 mm implant was deployed in the mid rca and a 3.5 x 18 mm implant was deployed in the proximal rca post-dilatation was done with a 3.75 x 15 mm nc trek balloon.The final angiographic residual stenosis was less than 10%.No additional information was provided.
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Manufacturer Narrative
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(b)(4).The device was not returned for evaluation.A cine of the procedure was returned and reviewed by an abbott vascular clinical specialist who confirmed the dissection.The reported patient effect of intimal dissection is listed in the nc trek rx instructions for use (ifu) as a known patient effect.Additionally, the ifu warns: balloon pressure should not exceed the rated burst pressure (rbp).The rbp for the nc trek rx device is 18 atms; therefore rbp was exceeded.There is no indication of a product quality issue with respect to manufacture, design or labeling.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.Based on the case information, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.
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Search Alerts/Recalls
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