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Catalog Number 532X |
Device Problem
Difficult to Remove (1528)
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Patient Problems
Pain (1994); Vasoconstriction (2126)
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Event Date 10/05/2017 |
Event Type
Injury
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Manufacturer Narrative
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Manufacturing records (dhr) could not be performed as the product catalog and lot number were not available.The product is available for evaluation and testing.However, the product has not been returned as of to date.Additional information will be submitted within 30 days upon receipt.
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Event Description
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As reported, during a catheter angioplasty procedure using an unknown guiding catheter, the patient developed right radial spasm.However, using 4 fr.Catheters, the physician was able to finish the angiogram/procedure and take all of the views needed.At the end of the procedure, and while taking the catheter out, the patient developed right radial pain.Further catheter movement/manipulation was not possible.Catheter screening revealed that there was a loop formed just above the radial sheath not allowing any manipulation.The patient was given pain and relaxing medications for treatment.Anesthetic support was obtained.Vascular input was also obtained.The patient was reported to have experienced an injury to the right arm that was moderate.The product is available for inspection.
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Manufacturer Narrative
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Additional information received: the product was returned for inspection.The preliminary comments indicated that the device was received in pieces.The product was returned for evaluation and testing; however, the engineering evaluation is not complete.Additional information will be submitted within 30 days upon receipt.
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Manufacturer Narrative
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Corrected data: please note that the product catalog number was corrected to: 532x.The event description was also updated to reflect the correct product/cardiology diagnostic catheter.As reported, during an angioplasty procedure using an unknown diagnostic catheter, the patient developed a right radial spasm.Catheter screening revealed that there was a loop that formed just above the radial sheath not allowing any manipulation.Using 4 f catheters, the physician was able to finish the procedure and take all the views needed.At the end of the procedure, while removing the catheter, the patient developed right radial pain.The patient was reported to have experienced an injury to the right arm that was moderate.The patient was given pain and relaxing medications for treatment.Anesthetic support was obtained.Vascular input was also obtained.The product was returned for inspection.A non-sterile unit of an unknown 5.2 f diagnostic catheter along with an unknown non-cordis sheath introducer were received for analysis inside a plastic bag.Per visual analysis, the catheter was received cut in three pieces.One the of the pieces was received fully inserted into the introducer.The catheter was noted cut at 77.7 cm from hub and at 17.3 cm from distal tip.Also, kink conditions were noted on one of the received catheters body shaft pieces.No other anomalies were found.A product history review could not be performed due to the device lot number being unknown.The event reported by the customer as ¿catheter (body/shaft)- withdrawal difficulty¿ could not be properly evaluated due to the condition of the unit as received (cut in pieces).The exact cause of the kinked and cut conditions on the body shaft of catheter could not be conclusively determined during the analysis.Based on the limited information available for review, procedural and handling factors, as well as vessel characteristics (while unknown) may have contributed to the event.According to the general instructions for use for angiographic catheters, which is not intended as a mitigation, ¿to prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter, exercise care when removing guidewires from multiple-curve catheters.To prevent kinking of 5f (1.65 mm) and smaller angiographic catheters, use a guidewire when introducing the catheter through the catheter sheath introducer (csi).The performance of these products may be impaired if not properly and cautiously handled during unpacking and preparation.The product analysis does not suggest that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time.
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Event Description
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As reported, during a catheter angioplasty procedure using an unknown diagnostic cardiology catheter, the patient developed right radial spasm.However, using 4 fr.Catheters, the physician was able to finish the angiogram/procedure and take all of the views needed.At the end of the procedure, and while taking the catheter out, the patient developed right radial pain.Further catheter movement/manipulation was not possible.Catheter screening revealed that there was a loop formed just above the radial sheath not allowing any manipulation.The patient was given pain and relaxing medications for treatment.Anesthetic support was obtained.Vascular input was also obtained.The patient was reported to have experienced an injury to the right arm that was moderate.The product is available for inspection.
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Search Alerts/Recalls
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