MAUDE Adverse Event Report: COOK INC APPROACH HYDRO ST MICROWIRE WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number	G52939
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
As reported, during an angioplasty procedure under general anesthesia, the tip of an approach hydro st microwire wire guide separated in the patient.The wire separated as the user was performing subintimal crossing of the occluded dorsalis pedis artery.The wire was unable to be retrieved.Per the physician, the wire will not cause any clinical consequences, as the dorsalis pedis artery is already occluded.The procedure was completed; however, angioplasty failed due to the patient's complex peripheral artery disease.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.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 received 27oct2023.Access was obtained in the femoral artery.The anatomy was heavily calcified and the dorsalis pedis artery was 80% occluded.The wire was not altered prior to use.Resistance was not felt upon insertion of the wire and the wire was not manipulated/pulled backward through the needle or any other metal instrument.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during an angioplasty procedure under general anesthesia, the tip of an approach hydro st microwire wire guide separated in the patient.The wire separated as the user was performing subintimal crossing of the occluded dorsalis pedis artery.The wire was unable to be retrieved.Per the physician, the wire will not cause any clinical consequences, as the dorsalis pedis artery is already occluded.The procedure was completed; however, angioplasty failed due to the patient's complex peripheral artery disease.Additional information was received (b)(6) 2023.Access was obtained in the femoral artery.The anatomy was heavily calcified and the dorsalis pedis artery was 80% occluded.The wire was not altered prior to use.Resistance was not felt upon insertion of the wire and the wire was not manipulated/pulled backward through the needle or any other metal instrument.Investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures were conducted during the investigation.A visual inspection of the complaint device was also conducted.The complaint device was returned to cook for investigation.The wire was unraveled near the distal end, beginning approximately 297-centimeters from the proximal end.A small non-unraveled portion at the distal end measured 2.5-centimeters.One millimeter of unraveled wire was sticking out from the distal end of the non-unraveled section, and the distal tip of the wire was missing.A document-based investigation evaluation was performed.A review of the device history record found no relevant non-conformances on the lot.A review of complaint history found no additional complaints for this lot number.The product ifu warns that the wire is a delicate instrument and says that forceful angulation should be avoided.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 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.Based on the information provided and the results of the investigation, cook has concluded that the patient¿s anatomy contributed to this event, as the anatomy was heavily calcified, the patient had complex peripheral artery disease, and the wire separated as it was being used for subintimal crossing of an eighty percent occluded artery.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
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Udi related data quality updates only.Correction: d4.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.

• Brand Name: APPROACH HYDRO ST MICROWIRE 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: 17986636
• Report Number: 1820334-2023-01424
• Device Sequence Number: 12803635
• Product Code: DQX
• UDI-Device Identifier: 00827002529397
• UDI-Public: (01)00827002529397(17)240918(10)15559857
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K091385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/18/2024
• Device Model Number: G52939
• Device Catalogue Number: HMW-14-300-ST
• Device Lot Number: 15559857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/10/2023
• Supplement Date Received by Manufacturer: 10/27/2023; 01/08/2024; 08/06/2024
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 11/02/2023; 01/19/2024; 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2023
• 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: 2MM X 8CM 0.14" ARMADA BALLOON.; DESTINATION 6 FR 45CM SHEATH.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown