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Blank fields on this form indicate the information is unknown, unchanged or unavailable.Additional information: b5 d10 ¿ product received on: 31mar2021.Investigation ¿ evaluation port macquarie base hospital reported an incident involving a straight and curved double flexible tipped wire guide.The complainant reported that the device snapped during an angiogram procedure.This failure occurred with a total of 3 devices, from the same lot, during 3 different angiograms on 3 different patients on 06jan2021.Three records were initiated for each patient reported in report reference #¿s: 1820334-2021-00078, 1820334-2021-00079.Attempts to acquire additional information from the user facility were executed, however no additional information was provided to cook in response to this incident.The patient reportedly experienced no adverse effects as a result of this incident.A review of documentation including the complaint history, device history record, instructions for use (ifu), manufacturing instructions, quality control and specifications, as well as a visual inspection of the returned device was conducted during the investigation.One used wire was returned for evaluation.A physical examination of the device showed a broken tip weld at the ¿j¿ curved end, with subsequent coil offset 4.0 cm and 4.3cm from the weld.There is no evidence that the device was manufactured out of specification.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) found that sufficient inspection activities are in place to identify the failure mode prior to distribution.A review of the design history file (dhf) found that the risks associated with this device were acceptable when weighed against the benefits.A review of the device history record (dhr) for the complaint lot recorded 10 related nonconformances, in which 8 devices were scrapped for ¿bent/kinked¿ and 2 devices were scrapped for ¿weld not caught.¿ it should be noted that 4 complaints were associated with this lot number.Two of those complaints were reported from the same customer for the same issue, while the other two complaints were reported for shipping with an unapproved ifu.Although these non-conformances are relevant to the reported failure mode, all non-conforming product was scrapped, there are 100% inspections to capture this non-conformance.Adequate inspection activities have been established, there is objective evidence that the dhr was fully executed.There are no other lot related complaints with similar failure modes, outside of the associated incidents from the same user facility, have been received from the field, it was concluded that there is no evidence that non-conforming product exists in house or in field.The instructions for use (ifu), provides the following information related to the reported failure mode: ¿warnings this product is a delicate instrument.Avoid forceful angulation.Avoid manipulating or withdrawing the wire guide back through a metal needle or cannula.A sharp edge may scrape or shear material from the wire guide.Altering the tip¿s configuration or curve manually may damage the wire guide.Excessive tightening of a torque device may abrade the coating on the wire guide.¿ ¿precautions do not advance or withdraw a wire guide when resistance is encountered, as a perforation could occur.Inspect the wire guide for kinks or damage prior to use.¿ ¿how supplied supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened and undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the information provided, examination of the returned product and the results of our investigation, a definitive root cause for the failure could not be established.It is possible that operational factors could have contributed to the failure mode that occurred with 3 devices at the same user facility on the same day, but this could not be confirmed.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.We will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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