|
Blank fields on this form indicate the information is unknown or unavailable.E1: customer name and address = line 2: (b)(6).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.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.
|
|
As reported, the polymer jacket separated from the tip of the hiwire nitinol hydrophilic wire guide, prior to an unknown procedure.The coating was activated by injecting saline.The damage was observed before the wire guide was removed from the holder.The procedure was complete by using another same device.The complaint device did not make contact with the patient.The patient did not experience any adverse effects due to this occurrence.
|
|
Event description: as reported, the polymer jacket separated from the tip of the hiwire nitinol hydrophilic wire guide, prior to an unknown procedure.The coating was activated by injecting saline.The damage was observed before the wire guide was removed from the holder.The procedure was complete by using another same device.The complaint device did not make contact with the patient.The patient did not experience any adverse effects due to this occurrence.Investigation ¿ evaluation a visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record (dhr), the instructions for use (ifu), and quality control procedures.One hiwire nitinol hydrophilic wire guide was returned for investigation.The tip of the wire guide was observed to have the wire core exposed as reported.The dispenser assembly was not returned with the device.The overall length of the device was 150.2 cm and a finished diameter of.03235¿ to.03290¿.A gage bushing certified to be.0350¿ passed over the length of the specimen with no more effort than the mass of the bushing sliding down the wire shaft unaided, except by gravity to the proximal aspect of the tip damage.After wetting the device with blood-bank saline, the specimen was subjected to visual and tactile examination.The specimen coating appeared visually and tactilely consistent when examined at 1x ¿ 18 inches, unaided, wet.The specimen presented 0.3 cm of the metallic core wire protruding through the polymer jacket 0.5 cm from the distal tip.The polymer jacket material presented indication of tensile distortion (stretching) in the vicinity of the core wire protrusion.Except where noted, the specimen device appeared visually and dimensionally correct.The wire guide is assembled and packaged by a supplier who completed a dhr review as part of their investigation.The incoming inspection records at cook were reviewed and the lot passed incoming inspection.A review of the device history record by cook and the supplier found no non-conformances related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.A review of manufacturing procedures by the supplier found multiple inspections to be in place to assure the integrity of the wire guide prior to shipment.The evidence from the complaint file, device history record, complaint history and the supplier investigation indicates that the complaint device was manufactured to specification as well as other items in the lot or similar devices in the field or in house.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: instructions for activating hydrophilic coating the hydrophilic coating on the wire guide is activated by immersion in sterile water or sterile saline solution.1.Prior to using the wire guide, fill a syringe with sterile water or sterile water or sterile saline solution and attach it to the flushing port on the wire guide.2.Inject enough solution to wet the wire guide surface entirely.This will activate the hydrophilic coating.A specific cause of the complaint could not be established.Clinical / procedural factors could not be ruled out, as the nature of this damage is representative of attempting to remove the wire guide from the dispenser hoop without proper hydration.Per the quality engineering risk assessment, no further action is required.The appropriate personnel have been notified, and we will continue to monitor for similar complaints.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.
|
