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Catalog Number 5MAXACE132 |
Device Problems
Fluid/Blood Leak (1250); Hole In Material (1293)
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Patient Problem
Blood Loss (2597)
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Event Date 02/09/2015 |
Event Type
malfunction
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Event Description
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The patient was undergoing a thrombectomy procedure using a penumbra system 5max ace reperfusion catheter.During the procedure, the physician noticed that there was blood leaking from the proximal end of the ace catheter.A second ace catheter was used, however, it encountered the same problem.Upon removing a new ace catheter from the packaging, a hole was noticed on the proximal end.The physician was able to successfully complete the procedure by covering the hole in the ace catheter with his finger.There was no report of an adverse effect on the patient.
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Manufacturer Narrative
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Conclusion: the device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This mdr is associated with mdr 3005168196-2015-00225, 00226.
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Manufacturer Narrative
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Result 5max ace was fractured approximately 1.6 cm from the hub, under the strain relief.Conclusion: the complaint has been evaluated.The complaint indicated a fracture in the proximal shaft of three 5max ace catheters.Evaluation of the returned devices confirmed all were fractured in the proximal shaft, and revealed the third catheter was kinked in the proximal shaft.This type of damage typically occurs when the device is improperly handled during removal from packaging or during preparation for use.If the catheter is removed from the packaging hoop at an angle or manipulated at an angle during insertion into the patient, the shaft may fracture due to excess force and bending of the catheter.These devices are 100% visually inspected for damage during process inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
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Search Alerts/Recalls
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