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It was reported that during an intravascular ultrasound, via the iliac vein, the triforce¿ peripheral crossing set began tearing at the tip upon removal from the patient's anatomy.According to the complainant, the complaint device removal was not difficult and no portion remained in the patient.The procedure was successfully completed using another type of device.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
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Investigation evaluation.A review of the complaint history, device history record, drawing, manufactures instructions, and quality control of the device were 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.A review of the 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.Additionally, it should be noted that the non-inventory component order for the outer sheath of the device was also reviewed, and no nonconformances were noted.However, when looking at the subassembly work orders for outer sheaths, lots sa6777719 & sa6777720 were reviewed and four nonconformances were discovered.For sa6777719 one nonconformance was noted for rough end hole, and a second was noted for split tip.While these were potentially related, the affected devices were scrapped and not replaced.The two nonconformances noted for sa6777720 were for a leakage and surface defect respectively.Both devices did not appear to be related to the failure and were scrapped and not replace prior to order completion.Furthermore, a review of the non-inventory component order for the inner sheath was performance and no nonconformances were noted.However, upon reviewed the subassembly work order lot sa6782736 two nonconformances were noted.One was for a separated bond, and the other an inadequate tip.While these are potentially related, it should be noted that both affected devices were scrapped and not replaced.Moreover, for this case, it was not clarified what was meant by tearing, or which component of the device tore.Given this, various testing of each component breaking or separating was reviewed and referenced as representative device testing.For all tests, all test articles passed, and the average value for each test was well above the requirement.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be established.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Measures are being conducted to address this failure mode.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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