Catalog Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fistula (1862); Thrombosis (2100)
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Event Date 07/03/2016 |
Event Type
Injury
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Manufacturer Narrative
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Common name & product code = unavailable as the device lot number, rpn, and gpn are unknown.(b)(4).Pma/510(k) number = unavailable as the device lot number, rpn, and gpn are unknown.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.Ding, pockett, moore, and el-said, (2016), long sheath us in femoral artery catheterizations in infants <15 kg is associated with a higher thrombosis rate: proposed protocol for detection and management, vol (88) pp.1108-1112 catheterization and cardiovascular interventions.Information retrieved from doi: 10.1002/ccd.26690.
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Event Description
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A journal article was reviewed titled, "long sheath use in femoral artery catheterizations in infants <15 kg is associated with a higher thrombosis rate: proposed protocol for detection and management".This retrospective study was undertaken to examine the factors contributing to arterial thrombosis after catheterization, particularly the use of long vs.Short introducer sheaths and to propose a new protocol to address the risks.The author reported, between february 2006 and june 2014, twenty-nine cases were identified in which an arterial long sheath was used and forty matched interventional cases were selected in which a short sheath was used.The total cohort (69) consisted of 59% males and 41% females.Patient¿s age ranged from 1 day to 4.5 years (mean 11.6 ± 15.1 months), and weight ranged from 2.6 to 14.8 kilograms (kg) (mean 7.0 ± 3.9 kg).Of the patients who received a long sheath, ten received a 4fr 75 cm sheath (cook medical, (b)(4)), and nineteen received a 4fr 45 cm sheath (cook medical, (b)(4)).A total of 17/69 had arterial compromise, sixteen of the seventeen had decreased pulses and or a confirmed thrombus (eleven in the long sheath group, five in the short sheath group).One patient had a fistula in one femoral artery and a thrombus in the other, which resulted in severe limb discrepancy.The incidence of arterial compromise was 38% (11/29) in the long sheath group compared to 15% (6/40) in the short sheath group and was statistically significant (p¼0.029).Neither time to arterial access nor the sheath implant duration was statistically significant between the groups.Weight was an independent risk factor, with infants <5 kg having a higher complication rate compared to infants >5 kg at 38.2% (13/34) and 11.4% (4/35), respectively (p¼0.004).Sheath length remained statistically significant after performing logistic regression analysis with weight and age as covariates (p¼0.011).The odds ratio of long versus short sheaths for arterial compromise was 3.46 (95% ci:1.10¿10.91).When analyzing sheath to artery ratio, there was a significant difference between the complication and non-complication group (p¼0.0017).Patients who had arterial complications were found to have a larger sheath to artery ratio (0.996) compared to those who did not have complications (0.694), which is consistent with previous findings that larger sheath french is correlated with higher rates of arterial compromise.In total, arterial compromise was documented by ultrasound, computed tomography (ct), or angiography in 71% (12/17) of patients with complications, the remaining 29% (5/17) had decreased pulses on exam.Fourteen patients had early detection of arterial compromise (within two weeks of the procedure).Of those, ten received heparin or tpa therapy with good resolution, two recovered spontaneously, and two were lost to follow up.Three patients had late detection of arterial compromise.Of those, two developed collateral blood flow, and one patient had a leg length and width discrepancy.The patient with a fistula and leg discrepancy underwent surgical ligation of the fistula with improved leg length disparity.The author concluded that weight and sheath length are both statistically significant contributors to complication rate.Lower patient weight is also a contributing factor to increased incidence of complication, particularly in those <5 kg.This report is for both the short and long sheaths as neither catalog information, nor lot numbers have been provided.
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Event Description
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No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.Refer to section h10 for investigation findings.
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Manufacturer Narrative
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Investigation evaluation.A review of the documentation, drawing, instructions for use (ifu), and specifications was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.The lot number of the device is not known; accordingly, a review of the device history record could not be conducted.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Search Alerts/Recalls
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