It was reported that the wire guide in a fuhrman pleural/pneumopericardial drainage set separated.The device was required by a (b)(6) male for pleural drainage.During the procedure, after placing the catheter, the user pulled on the wire guide and discovered it was "split." the user then obtained another device of the same lot and again attempted to place the catheter.During removal of the replacement wire guide, the wire again broke.In this occurrence, a portion of the wire remained in the patient.Subsequently, the user was able to remove the remnant of the wire "by pulling the drainage." the procedure was completed by obtaining a third device.No other adverse effects were reported for this incident.Two photos provided by the customer depict an unraveled wire guide and a separated wire guide.This report will focus on the second wire guide separation.The broken wire guide has been reported under patient identifier (b)(6).
|
It was reported that the wire guide in a fuhrman pleural/pneumopericardial drainage set separated.The device was required by a (b)(6) male for pleural drainage.During the procedure, after placing the catheter, the user pulled on the wire guide and discovered it was "split." the user then obtained another device of the same lot and again attempted to place the catheter.During removal of the replacement wire guide, the wire again broke.In this occurrence, a portion of the wire remained in the patient.Subsequently, the user was able to remove the remnant of the wire "by pulling the drainage." the procedure was completed by obtaining a third device.No other adverse effects were reported for this incident.Two photos provided by the customer depict an unraveled wire guide and a separated wire guide.This report will focus on the second wire guide separation.The broken wire guide has been reported under patient identifier (b)(6).
|
Investigation ¿ evaluation: a complaint was received from a representative at the universitätsklinikum bonn, located in the city of bonn, germany.They reported, upon placement of the 8.5 fr pigtail catheter from the fuhrman pleural/pneumopericardial drainage set (c-ppd-850-wce-imh, lot number 14134748) on a three-year-old patient, the supplied wire guide (thscf-28-40-2-aes) "split open." this occurred during the attempt to withdraw the wire.A portion of the wire remained in the patient.Subsequently, the user was able to remove the remnant of the wire "by pulling the drainage." a review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control procedures, as well as a visual inspection of the returned product, were conducted during the investigation.The supplied thscf-28-40-2-aes, amplatz wire guide was returned in a used and damaged condition.The investigation discovered two sections of the wire guide has separated from the main shaft.One section exhibited extreme coil elongation, while the remaining section exhibited some coil elongation, with the presence of the weld ball.The main section of the wire guide also exhibited coil elongation, resulting in the exposure of the inner mandril wire.The o.D.Of the undamaged coil was confirmed to be within specification.Additionally, a document based investigation evaluation was performed.A device master record (dmr) review was performed, and device specifications, manufacturing instructions (mi) and quality control (qc) procedures associated with the complaint were identified.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The device history record (dhr), wire guide subassembly lot revealed there was one relevant recorded nonconformance, but these devices were scrapped prior to further processing.To date, a further search of our database confirmed one additional complaint from the reported lot (reported under 1820334-2021-02743).This complaint was received from the same customer regarding the same procedure and having similar difficulties with the supplied wire guide.Since there is objective evidence the dhr was executed, in addition to no evidence of nonconforming material in house or in the field, cook medical concluded that the device was manufactured to specification.The device is shipped with instruction for use (ifu) which provides the following information to the user related to the reported failure mode: how supplied: "upon removal from package, inspect the product to ensure no damage has occurred." it can not be ruled out that the noted damage could be a result of manipulation and/or withdrawal of the wire guide while the needle was still in place; however this is only a speculation.Based on the information provided, the examination of returned product and the results of the investigation, the cause was traced to a component failure.The appropriate internal personnel have been notified.Per the risk assessment, no further action is required.Cook 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.
|