|
In additional information provided on 21sep2022, it was confirmed by the distributor that the second wire was fractured in the same way as the first wire guide.On 23sep2022, the distributor later reported that two cook wires were used in the procedure.The device with lot #: 14141571 (captured report with mfg.Report reference #: 1820334-2022-01389) was lost by the nurse and will not be returned.Only one device (captured in this event) has been received by the manufacturer.The returned black wire is a competitor wire; however, no additional information on the wire could be provided by the facility.
|
|
Additional information was provided on 26aug2022.The procedure was a percutaneous transhepatic cholangio drain placement for advanced intrahepatic cholangiocarcinoma.The puncture needle was inserted into the bile duct and the wire was advance to the target location.The needle was then withdrawn.The "grey soft catheter" passed the tip of the wire into the bile duct, as noted in fluoroscopy imaging, when the wire guide "broke" in the patient.The user felt "the support force weakened" and suspected the wire fractured.The wire and soft catheter were removed together, and the wire was noted to be "broken" in the catheter.No further information has been provided related to the second wire that "broke" during the procedure.(captured in this report).Two cook wire guides were returned in association with this incident.One wire was unraveled and the other was undamaged.A third, unknown manufacturer wire was also returned unraveled.
|
|
Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Correction: h6 (annex a).Investigation ¿ evaluation.Heshuo medical technology co., ltd.(china) contacted cook on 16aug2022 concerning a neff percutaneous access set (rpn: npas-100-rh-nt; lot# 14151478.).The customer stated that the wire guide broke during a ptcd procedure for advanced intrahepatic cholangiocarcinoma on 12jul2022.This wire guide was used to replace the first wire guide which was used and broke (medwatch ref #1820334-2022-01389).The procedure was completed with another new device.No part of the product remained within the patient.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.Reviews of the complaint history, device history record (dhr), manufacturing instructions, and quality control procedures, as well as a visual inspection of the returned device, were conducted during the investigation.The product was returned to cook for evaluation.The wire guide was unraveled and elongated at the distal end.One damaged pmg wire guide, one undamaged wire guide, one damaged competitor black wire guide, an unknown catheter, and other components from a cook ult drainage set were returned.Due to the damaged condition of the wire guide, relevant measurements could not be taken.Additionally, a document-based investigation evaluation was performed.In response to this incident, cook completed a review of the product device master record (dmr) and concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook also reviewed the device history record (dhr).The dhr for lot# 14151478 records no relevant non-conformances.Ic13974842 (wire guide) had one relevant non-conformance where one device was scrapped due to stretched coil.Ic13974842 and all other related subassembly lots did not have any non-conformances.A database search for complaints on the reported lot found no additional complaints reported from the field.Based on the device master record, the device history record, and the device failure analysis, cook found no evidence the product was manufactured out of specification.There is no evidence of non-conforming material in house or in the field.This product is not supplied with an instructions for use (ifu) pamphlet.Based on the information provided, examination of the returned device and the results of the investigation, cook has concluded that component failure unrelated to manufacturing or design deficiencies contributed to the event.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.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.
|
