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

Model Number G53971

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Name and address for importer site: (b)(4).Similar to devices under pma/510(k): k061670.Investigation is still in progress.

Event Description

Description of event according to initial reporter: the physician planned to use the device for tavi, and the access was obtained from femoral artery.He inserted the complaint wire guide into the access before the placement of tavi under fluoroscopy.However, it was more difficult for him to confirm the impermeable part of its tip than usual.Therefore, the physician replaced the complaint device for a new tscmg-35-300-e-lesdc (different lot one) to complete the procedure.Patient outcome: no adverse effects to the patient.

Manufacturer Narrative

Exemption number (b)(4).William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturers ref# (b)(4).Name and address for importer site: (b)(4).Summary of investigational findings: it was reported to be more difficult to confirm the impermeable tip of the wire guide than usual.However, the procedure completed with another wire and without any adverse effects to the patient.The wire guide was returned inside the holder and an investigation found no damages to the wire guide, but a slightly larger curve than prescribed, likely because attempts had been made to alter the tip prior to use.The wire guide was cut open and revealed the inner gold coil, which must be included for enhanced visibility, thus finding that the wire guide was manufactured according to specifications.Unfortunately, no imaging was provided to confirm the less "impermeable part of its tip than usual" and based on the investigation findings the exact reason for the difficulties encountered cannot be determined.No evidence to suggest that this device was not manufactured according to specifications.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 Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: LUNDERQUIST EXTRA-STIFF DOUBLE CURVED EXCHANGE SUPPORT WIRE GUIDE
• Type of Device: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 8168497
• MDR Text Key: 130623854
• Report Number: 3002808486-2018-01526
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 00827002539716
• UDI-Public: (01)00827002539716(17)220509(10)E3581864
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 03/22/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 05/09/2022
• Device Model Number: G53971
• Device Catalogue Number: TSCMG-35-300-E-LESDC
• Device Lot Number: E3581864
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2018
• Distributor Facility Aware Date: 12/04/2018
• Device Age: 18 MO
• Initial Date Manufacturer Received: 12/03/2018
• Initial Date FDA Received: 12/17/2018
• Supplement Dates Manufacturer Received: 03/07/2019
• Supplement Dates FDA Received: 03/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1