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

Model Number	G09782
Medical Device Problem Codes	Peeled/Delaminated (1454); Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during a below-the-knee angioplasty and atherectomy, the coating of a bentson plus fixed core wire guide came off of the device.The device was advanced via antegrade approach from the groin down the superficial femoral artery to the pedal artery.Another manufacturer's catheter was advanced over the wire, and the wire was attempted to be removed to exchange for a crossing wire.When removing the wire, coating was noted to have scraped off a small section of the distal end of the wire, and the tip integrity was degraded.The wire was difficult to remove from the catheter.A small amount of thrombus was pulled by the wire.The wire was eventually able to be completely removed from the catheter.The patient did not require any additional intervention due to this occurrence.The patient did not experience any adverse effects due to this occurrence.Additional event information has been requested.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.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
Additional information was received 16mar2022.The vessel was calcified.The wire was not manipulated prior to use.The target location was the femoral/popliteal arteries.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as originally reported, during a below-the-knee angioplasty and atherectomy, the coating of a bentson plus fixed core wire guide came off of the device.The device was advanced via antegrade approach from the groin down the superficial femoral artery to the pedal artery.Another manufacturer's catheter was advanced over the wire, and the wire was attempted to be removed to exchange for a crossing wire.When removing the wire, coating was noted to have scraped off a small section of the distal end of the wire, and the tip integrity was degraded.The wire was difficult to remove from the catheter.A small amount of thrombus was pulled by the wire.The wire was eventually able to be completely removed from the catheter.The vessel was calcified.The wire was not manipulated prior to use.The target location was the femoral/popliteal arteries.The patient did not require any additional intervention due to this occurrence.The patient did not experience any adverse effects due to this occurrence.Additional information: b5, h6 (annex a, g) investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, specifications, and quality control procedures were conducted during the investigation.A visual inspection of the complaint device was also conducted.The complaint device was returned for investigation.The coating was not peeling/separating from the device as originally reported; however, the coils were unraveling near the distal end of the wire guide.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 product ifu cautions the user to inspect the product for kinks or damage prior to use.The information provided upon review of the dmr, dhr, ifu, and investigation of the returned device 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.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the information provided and the results of the investigation, cook has concluded that the patient¿s calcified anatomy 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.
Event or Problem Description
Upon receipt and evaluation of the device, the coating was not coming off of the wire; however, the coils were beginning to unravel.

• Brand Name: BENTSON PLUS 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: 13790733
• Report Number: 1820334-2022-00401
• Device Sequence Number: 3905776
• Product Code: DQX
• UDI-Device Identifier: 00827002097827
• UDI-Public: (01)00827002097827(17)270111(10)14448274
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,Followup
• Report Date (Section B): 09/01/2022

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: G09782
• Device Catalogue Number: TSFBP-35-180
• Device Lot Number: 14448274
• 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: 03/04/2022
• Supplement Date Received by Manufacturer: 03/16/2022; 03/22/2022
• Initial Report FDA Received Date: 03/17/2022
• Supplement Report FDA Received Date: 04/14/2022; 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2022
• 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: BARD SEEKER CATHETER
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Weight: 77 KG