FDA Adverse Event Malfunction Summary report: N

LUNDERQUIST SUPPORT WIRE GUIDE

MDR report key: 25160838 · Received May 13, 2026

Report

Report Number: 3002808486-2026-00085
Event Type: Malfunction
Date Received: May 13, 2026
Date of Event: April 16, 2026
Report Date: May 13, 2026
Manufacturer: WILLIAM COOK EUROPE
Product Code: DQX
UDI-DI: 00827002492271
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

MANUFACTURERS REF# (B)(4). BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. G4) SIMILAR TO DEVICE MARKETED UNDER 510(K)/PMA: K220137. INVESTIGATION IS STILL IN PROGRESS. 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.

Description of Event or Problem · 0

DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: WE EXPERIENCED A MALFUNCTION IN THE OPERATING ROOM ON (B)(6) 2026. WHEN USING A LUNDERQUIST GUIDE, TSMG-35-145-7, THE WIRES CAME APART IN THE MIDDLE OF THE GUIDE, THE END WAS BARELY ATTACHED. PATIENT OUTCOME: NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
27853	LUNDERQUIST SUPPORT WIRE GUIDE	DQX WIRE, GUIDE, CATHETER	DQX	WILLIAM COOK EUROPE	G49227	E4811959	00827002492271

Patients

Seq	Age	Sex	Outcome	Treatment
1