FDA Adverse Event Malfunction Summary report: N

ROCKET

MDR report key: 23973548 · Received January 6, 2026

Report

Report Number
23973548
Event Type
Malfunction
Date Received
January 6, 2026
Date of Event
November 24, 2025
Report Date
December 4, 2025
Manufacturer
ROCKET MEDICAL PLC
Product Code
DWM
Product Problem
Yes
Report Source
User Facility report
Reporter Location
PA
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Description of Event or Problem · 0

PATIENT HAD ROCKET DRAIN PLACED FOR RECURRENT MALIGNANT PLEURAL EFFUSION. ROUTINE POST OP CXR DETERMINED A PORTION OF THE GUIDEWIRE WAS RETAINED. PATIENT WAS TAKEN BACK TO THE OR THE SAME DAY FOR RIGHT VATS [VIDEO-ASSISTED THORACOSCOPIC SURGERY] REMOVAL OF INTRAPLEURAL FOREIGN BODY. PATIENT WAS DISCHARGED THE FOLLOWING DAY. SURGEON STATED SHE HAS DONE MORE THAN 1000 OF THESE PROCEDURES HERSELF; IP [INTERVENTIONAL PULMONOLOGY] FELLOW WAS PERFORMING THIS PARTICULAR PROCEDURE WITH ATTENDING SURGEON SUPERVISING. THEY SWITCHED TO ROCKET CATHETERS BECAUSE THEY WILL PROVIDE THE PATIENT WITH SUPPLIES THAT INSURANCE DOES NOT COVER, ALTHOUGH NOTES THAT THEIR PROCEDURE IS SUBPAR- IT KINKS EASILY AND IS FLIMSY. SHE BELIEVES THIS EVENT WAS A COMBINATION OF TECHNIQUE ISSUE AND EQUIPMENT MALFUNCTION. THIS GUIDEWIRE IS BRAIDED/RAVELED TOGETHER, MUCH LIKE YARN. SHE BELIEVES THAT WHEN INTRODUCING THE NEEDLE, IT LIKELY SHEARED OFF/SEPARATED, LEAVING A PORTION OF THE GUIDEWIRE INSIDE THE PATIENT. WHEN THE GUIDEWIRE WAS PULLED OUT, IT WAS UNRAVELED/FRAYED, BUT STILL APPEARED TO BE THE FULL LENGTH OF THE ORIGINAL GUIDEWIRE AND ASSUMED THEY HAD REMOVED IT IN IT'S ENTIRETY. THIS PROCEDURE IS TYPICALLY DONE UNDER ULTRASOUND GUIDANCE AND POST OP XRAY IS STANDARD, NOT DONE INTRAOPERATIVELY. PER SURGEON, AFTER DISCUSSION WITH THE FELLOW THAT PERFORMED, SHE NOTED THAT SHE FELT AS THOUGH THERE WAS MORE RESISTANCE THAN NORMAL WHEN TRYING TO REMOVE THE GUIDEWIRE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
32638 ROCKET APPARATUS, SUCTION, PATIENT CARE DWM ROCKET MEDICAL PLC R51400-16-00 UNABLE TO DETERMINE

Patients

Seq Age Sex Outcome Treatment
1 82 YR Female Other