MAUDE Adverse Event Report: COOK INC BENTSON STRAIGHT FIXED CORE WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number	G01290
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during an unknown procedure, a bentson straight fixed core wire guide began to separate.Reportedly, when the user attempted to grasp and straighten the wire, the distal end would not straighten, and the wire began to separate at the "point of contact".A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Additional information has been requested.
Additional Manufacturer Narrative
G4: pma/510(k) number = 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 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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Corrected information: d9, h3 - the complaint device was not returned; however, unused product from the same lot was returned.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
Additional information was received 11sep2024.The access site is "typically" the right groin, and the wire was used with another manufacturer's catheter.The patient's anatomy was not stenosed, tortuous, calcified, or scarred.Resistance was not felt during insertion and the wire was not manipulated backward through a needle or other metal instrument during the procedure.
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
Summary of event: as reported, during an unknown procedure, a bentson straight fixed core wire guide began to separate.Reportedly, when the user attempted to grasp and straighten the wire, the distal end would not straighten, and the wire began to separate at the "point of contact".A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Additional information was received (b)(6) 2024.The access site is "typically" the right groin, and the wire was used with another manufacturer's catheter.The patient's anatomy was not stenosed, tortuous, calcified, or scarred.Resistance was not felt during insertion and the wire was not manipulated backward through a needle or other metal instrument during the procedure.Investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.The customer returned fifteen unused/sealed bentson straight fixed core wire guide¿s.As such, a visual inspection of these unused/sealed, returned devices was conducted.The complaint device was not retuned.Inspection of the unused/sealed devices found no damage to the wires.Slight relaxation of the coils was noted; however, upon investigation, the devices were determined to be manufactured to specification.A document-based investigation evaluation was also performed.No related non-conformances were found on the complaint lot or component lots, and there have been no other reported complaints for this lot number or component related lot numbers.The product instructions for use provides the following warning, ¿altering the tip¿s configuration or curve manually may damage the wire guide.¿ a review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The information provided upon review of the dmr, dhr, ifu, and investigation of the returned, sealed devices, suggests that there is evidence the device was manufactured to specification.There is no evidence of non-conforming devices in-house or in the field.The exact conditions experienced during the event cannot be duplicated and the complaint device was not returned.Therefore, based on the information provided and the results of the investigation, cook has concluded that component failure unrelated to manufacturing or design deficiencies contributed to this event.The risk analysis for this failure mode was reviewed and no additional escalation was required.The appropriate personnel have been notified and cook will continue to monitor for similar events.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: BENTSON STRAIGHT FIXED CORE 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: 20179473
• Report Number: 1820334-2024-01201
• Device Sequence Number: 8364752
• Product Code: DQX
• UDI-Device Identifier: 00827002012905
• UDI-Public: (01)00827002012905(17)290605(10)16092179
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/14/2025

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: G01290
• Device Catalogue Number: TSFB-35-180
• Device Lot Number: 16092179
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2024
• Supplement Date Received by Manufacturer: 09/11/2024; 01/15/2025
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 10/08/2024; 02/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SOS ANGIODYNAMICS CATHETER.
• Patient Sex: Unknown