MAUDE Adverse Event Report: COOK INC LUNDERQUIST-RING TORQUE INTERVENTIONAL WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number	N/A
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a lunderquist-ring torque interventional wire guide unraveled during preparation for a procedure.The unraveling occurred prior to patient contact and was noted at the proximal end of the wire.It was also noted that the wire guide insertion tool was not inserted through the valve assembly or hub of the guiding sheath before the tip of the wire guide was inserted.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
Initial reporter ¿ occupation: supply coordinator.Pma/510(k) #: k171764.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.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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Investigation evaluation: on (b)(6) 2022, (b)(6) (united states) contacted cook stating that during preparation for a procedure the lunderquist-ring torque interventional wire guide (rpn: thsf-35-125-thg, lot: 14385946) to be used unraveled at the hub.There were no adverse effects for the patient due to the wire not being used.The patient did not experience any additional procedures due to this occurrence.The wire guide insertion tool was not inserted through the valve assembly or hub of the guiding sheath before the tip of the wire guide was inserted.Reviews of the documentation, including the complaint history, device history record, instructions for use (ifu), manufacturing instructions (mi) and quality control procedures, as well as a visual inspection of the returned device, were conducted during the investigation.One prior to use lunderquist-ring torque interventional wire guide was received.Upon a visual examination, there was a slight coil elongation.It was less than 1mm confirmed at the bottom of the first anchor solder, closest to the distal weld.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that the product is 100% inspected for nonconformances during the manufacturing process.The device history record (dhr) for lot 14385946 was reviewed and found three relevant nonconformances.Two nonconformances were for a stretched coil, with each being scrapped.One nonconformance was for a bent or kinked wire with three being scrapped.It should be noted there are two other complaints associated with lot 14385946 for the same failure from the same customer.Cook also reviewed product labeling.This product is supplied with an instructions for use (ifu) pamphlet, t_fcwg_rev1.In the how supplied section it states: upon removal from package, inspect the product to ensure no damage has occurred.Evidence gathered from reviews of the dmr, the dhr, and the device failure analysis, cook was not able to find evidence the product was manufactured out of specification.There is no evidence of non-conforming material in house or in the field.Based on the information provided, examination of the returned product and the results of our investigation, a definitive cause for the failure could not be established.It is possible that the failure could be due to a component failure or due to damage incurred during transport.Per the 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.

• Brand Name: LUNDERQUIST-RING TORQUE INTERVENTIONAL WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 13801485
• Report Number: 1820334-2022-00414
• Device Sequence Number: 4005991
• Product Code: DQX
• UDI-Device Identifier: 00827002270312
• UDI-Public: (01)00827002270312(17)261217(10)14385946
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: THSF-35-125-THG
• Device Lot Number: 14385946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2022
• Supplement Date Received by Manufacturer: 11/01/2022
• Initial Report FDA Received Date: 03/17/2022
• Supplement Report FDA Received Date: 11/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown