MAUDE Adverse Event Report: WILLIAM COOK EUROPE LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number	G45208
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Pma/510(k): k171513.Investigation is still in progress.
Event or Problem Description
According to initial reporter: when advancing lunderquist(r) extra-stiff wire guide, the cardiac/peripheral vascular guidewire curled and perforated the iliac artery of the patient.A balloon was inserted to tamponade the bleeding.Vascular surgery was called in for repair of the iliac artery.Device malfunction - that is, the device did not do what it was supposed to do.Patient outcome: the patient did require additional procedures due to this occurrence.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Summary of investigational findings: the wire guide curled and perforated the iliac artery.A balloon was inserted to tamponade the bleeding and the artery was repaired by surgery.No product was returned and without the actual complaint device it would be inappropriate to speculate at what may or may not have caused the wire guide to curl and perforate the vessel.According to the instructions for use the wire guide is used both to assist in anatomical access for other devices and to support the delivery of medical devices and it must be carefully inserted in the peripheral vascular access catheter and advanced to the targeted site, but in the limited information provided there is no description of advancement through a catheter nor of the anatomy and consequently the tip of the wire guide may have damaged the vessel during advancement through a tortuous anatomy.There are adequate controls in place to ensure that the device was manufactured to specifications.It was assessed that because no non-conformances were detected, there is evidence that the dhr was fully executed.In addition, no other lot related complaints have been received from the field.It is therefore concluded that there is no evidence that nonconforming product exists in house or in field.Cook medical will continue to monitor for similar events.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 provided by customer on (b)(6) 2021: according to the medical record, this was an 85 year old, male, patient, 49.1 kg.There is nothing in the medical record to suggest a retained body following vascular surgery.According to the medical record, the patient was admitted for 7 days.No photos or video can be provided according to the medical record, access was achieved via the right common femoral artery.According to the medical record, the patient had hypertension, hypercholesterolemia, coronary artery disease, chronic kidney disease, symptomatic aortic valvular stenosis, myasthenia gravis, and bradycardia.What other medical devices were utilized in this case? the patient underwent a transaortic valve replacement.There were numerous medical devices use in this case.

• Brand Name: LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6, dk-4632; bjaeverskov
• Manufacturer Contact: lissi walmann ; sandet 6, dk-4632; bjaeverskov ; 56868686
• MDR Report Key: 12323509
• Report Number: 3002808486-2021-01706
• Device Sequence Number: 11451516
• Product Code: DQX
• UDI-Device Identifier: 00827002452084
• UDI-Public: (01)00827002452084(17)260610(10)E4120456
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2021

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: 06/10/2026
• Device Model Number: G45208
• Device Catalogue Number: TSCMG-35-260-LESDC
• Device Lot Number: E4120456
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/09/2021
• Supplement Date Received by Manufacturer: 12/08/2021
• Initial Report FDA Received Date: 08/16/2021
• Supplement Report FDA Received Date: 12/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Weight: 49 KG