It was reported the wire guide in a turbo-ject standard power injectable picc (peripherally inserted central catheter) was unable to be removed from the peel-away.The wire guide resembled a pigtail.To date, additional information regarding the device and patient has not been made available.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
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Investigation ¿ evaluation: a review of the dimensional verification, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, specifications, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the surface of the wire was in a damaged condition.The distal floppy tip appears to have been sheared off.The distal weld ball is missing.The coiling is missing from the distal tip.The sheared wire appears to have a pigtail shape.Also note, the proximal end of the wire appears to be in good condition.No damage was noted to the proximal end.No biological matter was visible on the damaged wire guide.No other damage was noted.Also of note, the dimensional length of the wire guide was noted.It was confirmed to be below tolerance however due to the damaged state it was received in, the wire guide was not out of specifications.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, the examination of the returned product, 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.
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