FDA Adverse Event Malfunction Summary report: N

PROGREAT

MDR report key: 25119836 · Received May 7, 2026

Report

Report Number: 9681834-2026-00106
Event Type: Malfunction
Date Received: May 7, 2026
Date of Event: April 15, 2026
Report Date: May 7, 2026
Manufacturer: TERUMO CORPORATION, ASHITAKA
Product Code: DQO
PMA / PMN Number: K033583
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PK
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

D4: UDI: N/A AS THIS PRODUCT CODE IS NOT EXPORTED TO THE US MARKET. D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. G4: 510K: K033913. HISTORY INVESTIGATION OF THE PRODUCT WITH THE INVOLVED PRODUCT CODE/LOT NUMBER NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD. NO OTHER SIMILAR REPORT WAS FOUND IN THE PAST COMPLAINT FILE. THE ACTUAL DEVICE WAS NOT AVAILABLE; THEREFORE, THE ACTUAL DEVICE WILL NOT BE RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. TERUMO MEDICAL CORPORATION (TMC) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834.

Description of Event or Problem · 0

TERUMO RECEIVED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT WHEN THE PRODUCT WAS USED, IT WAS FOUND HYDROPHILIC COATING OF THE GUIDEWIRE PEELED OFF. BASED ON THE PROVIDED IMAGE, URETHANE COATING WAS OBSERVED TO PEEL OFF. THE PROCEDURE OUTCOME WAS NOT REPORTED. THERE WAS NO HARM TO THE PATIENT REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 17-APRIL2026: THERE WERE NO FRAGMENTS LEFT IN THE PATIENTS BODY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
221849	PROGREAT	CATHETER, INTRAVASCULAR, DIAGNOSTIC	DQO	TERUMO CORPORATION, ASHITAKA	MC-PP27131	250702

Patients

Seq	Age	Sex	Outcome	Treatment
1