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Additional common device name: ffl dislodger, stone, basket, ureteral, metal concomitant medical products: terumo 035" guidewire, cook 5.0fr kmp catheter, terumo sheath.Occupation: unknown.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
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It was reported a wittich nitinol stone basket was used on an unknown patient for a biliary duct stone removal.When the operator tried to pull the stone out, the valve and catheter separated.A second device experienced the same failure.A new product was used to complete the procedure successfully.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
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Blank fields on this form indicate the information is unchanged, unknown or unavailable.D10 ¿ product received on: 30apr2020 investigation ¿ evaluation a representative from changwon gyeongsang national university reported an incident involving a wittich nitinol stone basket.On (b)(6) 2020 during a biliary duct stone removal procedure the valve and catheter separated during the removal of the biliary stone.After further communication it was confirmed this occurred on two devices for one patient.No unintended section of the device remained inside the patient¿s body, the patient did not require additional procedures due to this occurrence and there have been no adverse effects to the patient due to this occurrence.Upon return of the complaint device, the hub was separated from the introducer (sheath).Cook will address this complaint as hub separation from the introducer (sheath).A review of the drawing, instructions for use (ifu), manufacturing instructions, quality control, visual inspection, and dimensional verification, were conducted during the investigation.One basket was returned.Approximately 6.8cm of the gray dilator remained attached to the basket.The dilator was returned with a curve.The blue sheath was returned with the fitting separated.The fitting was not returned.There is no damage to the flare for the blue sheath.Part of the material for the loading sleeve was returned sheared off.All dimensions deemed relevant to the reported failure mode (sheath length, sheath tip id, sheath od) were analyzed and found the sheath¿s length was too long by.1mm.Additionally, a document based investigation evaluation was performed.Sufficient inspection activities are in place to identify this failure mode prior to distribution.In response to this incident, cook could not complete a review of the device history record (dhr) due to lack of lot information from the user facility.A global sales shipment report was conducted from 01jan2017 through 15mar2020 for the complaint device.Cook was unable to narrow down the lot this complaint pertains to.Due to missing information, there is no evidence suggesting nonconforming product from the affected lot exists in house or in the field.The product ifu, ¿wittich nitinol stone basket set,¿ provides the following information to the user related to the reported failure mode: instructions for use: ¿4.Insert the introducer sheath over the wire guide and across the percutaneous tract into anatomic structure.Position the radiopaque band of the sheath at or beyond the stone(s).5.Remove the wire guide and dilator from the sheath, leaving the sheath in position.¿ findings of this investigation revealed evidence to suggest the device may have been manufactured out of specification because the sheath¿s length was too long by.1mm.However, this could be a cascading event from the reported failure.The sheath tubing¿s material rfep is not very stretchy.However, if force was exerted on the sheath and caused the hub to separate, then this could also cause the sheath tubing to stretch.According to the drawings, the dilator is supposed to remain straight and the sheath is to have a slight curve.Upon return of the device, the dilator is curved and the sheath¿s curve looks stretched.Based on the returned condition of the dilator and sheath it is likely the sheath slightly stretched when withdrawn through the patient¿s anatomy.Based on the information provided, inspection of returned product, and the results of the investigation, it was concluded that a component failure without a manufacturing or design deficiency contributed to this incident.The appropriate personnel have been notified.Per the quality engineering 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.
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Product event summary: the full lead was returned and analyzed.The analysis indicated that the helix of the lead became extrinsically distorted due to pulling/stretching/overstress.Returned product analysis was performed and no anomalies were found.Visual analysis of the lead indicated damage at implant.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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