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

Model Number	G01290
Medical Device Problem Codes	Unraveled Material (1664); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, upon completion of two "standard" cerebral angiograms, the mandril protruded from two bentson straight fixed core wire guides (one wire in each case).The wires were used as intended to successfully complete the procedures; however, upon removal of the wires, the user noted that the mandril appeared to stick out from the teflon coating.The wires were not altered prior to use.The coating did not flake.A section of the device did not remain inside the body, and the patients were not hospitalized.The patients did not require any additional procedures or experience any adverse effects due to the events.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E3: occupation = "ir" 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
H3: device evaluated by mfg = other (81) - device evaluation has begun; however, a conclusion is not yet available.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.
Event or Problem Description
The complaint devices were returned to cook on 07oct2024.One wire was elongated with mandril protrusion.The other wire was elongated; however, mandril protrusion was not noted.
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
As reported, upon completion of two "standard" cerebral angiograms, the mandril protruded from two bentson straight fixed core wire guides (one wire in each case).The wires were used as intended to successfully complete the procedures; however, upon removal of the wires, the user noted that the mandril appeared to stick out from the teflon coating.The wires were not altered prior to use.The coating did not flake.A section of the device did not remain inside the body, and the patients were not hospitalized.The patients did not require any additional procedures or experience any adverse effects due to the events.The complaint devices were returned to cook on 07oct2024.One wire was elongated with mandril protrusion.The other wire was elongated; however, mandril protrusion was not noted.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.A visual inspection of the returned devices was also conducted.The complaint devices were returned to cook for investigation.Evaluation of the first device found the coils were elongated approximately 2.5 millimeters in length.The mandril was protruding approximately 13.4 centimeters from the floppy end of the wire guide.Elongation was also noted near where the mandril protruded.The weld solder balls were intact, and no damage was noted to the teflon coating.Evaluation of the second device found the coil was elongated approximately 3 millimeters in length, approximately 8.4 centimeters from the floppy end of the wire guide.The weld solder balls were intact, and no mandril protrusion or other damaged was noted to the second wire.A document-based investigation evaluation was performed.No related non-conformances were found, and there have been no other reported complaints for this lot number.The customer followed all relevant instructions in the instructions for use (ifu) related to this failure.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 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.Based on the information provided and the results of the investigation, cook has concluded that a component failure, unrelated to manufacturing or design deficiencies, contributed to this incident.The exact conditions experienced during the event cannot be duplicated.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: 20344149
• Report Number: 1820334-2024-01291
• Device Sequence Number: 8055128
• Product Code: DQX
• UDI-Device Identifier: 00827002012905
• UDI-Public: (01)00827002012905(17)290821(10)16216086
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 12/16/2024

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: 16216086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: 10/07/2024; 11/18/2024
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 10/18/2024; 12/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2024
• 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
• Patient Sex: Unknown