A representative of a spinal and orthopedic device manufacturer reported that a physician stated the ventriclear drainage catheter broke off during an unspecified procedure during insertion.Additional information was requested regarding retrieval of the device and patient outcome; however, at this time no further information is available from the initial reporter.The contact information for the reporting physician, including user facility information is not available.A statement that this event occurred multiple times cannot be validated.There is no further information available and the device is not available for evaluation.
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Investigation - evaluation: a review of the complaint history, device history record, documentation, drawing, instructions for use, quality control, trends and visual examination of the device was conducted during the investigation.A device failure analysis was completed by the supplier.Two open and used catheters were returned.Catheter 1: the catheter was returned in two pieces of lengths 20 cm and 12 cm respectively.Both edges at tear site appeared to be jagged.The returned segments were patent and passed leak testing when tested individually.Proteinaceous debris was observed within the interior and exterior of the catheter.Catheter 2: approximately 21cm of the catheter was returned.Both edges appeared to be jagged.The returned segment was patent and passed leak testing.Proteinaceous debris was observed within the interior and exterior of the catheter.A document based investigation evaluation was also performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows 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, evaluation of the returned device by the supplier and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Measures have been initiated to address this failure mode.Per the quality engineering risk assessment no further action is required.
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