PROGREAT

Report

Report Number: 9681834-2021-00087
Event Type: Malfunction
Date Received: May 28, 2021
Date of Event: April 20, 2021
Report Date: May 28, 2021
Product Code: DQO
PMA / PMN Number: K033583
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICE WAS NOT IMPLANTED. DEVICE WAS NOT EXPLANTED. PMA/510(K)- K033913, K170223. THIS REPORT HAS BEEN DEEMED REPORTABLE BASED UPON THE EVALUATION OF THE RECEIVED ACTUAL SAMPLE. VISUAL INSPECTION REVEALED THAT THE TIP OF THE COIL HAD BEEN CUT OFF, EXPOSING REINFORCING WIRE. IN ADDITION, WHITE FIBER WAS ENCLOSED IN THE PRODUCT. THEREFORE, WE CONSIDERED THAT THE "WIRE-LIKE OBJECT" MENTIONED IN THE EVEN DESCRIPTION REFERRED THE WHITE FIBER AND REINFORCING WIRE. MAGNIFYING INSPECTION OF THE VICINITY OF THE CUT FOUND THAT THE SHAFT HAD BEEN ELONGATED FROM THE TIP TO 22 MM FROM THE DISTAL END. CRUSHES WERE OBSERVED ON THIS AREA AT ALMOST EQUAL INTERVALS OF ABOUT 6 MM. THE LENGTH OF THE ACTUAL SAMPLE FROM THE CUT END TO THE KINK PROTECTOR WAS APPROXIMATELY 1301 MM. THE LENGTH OF THE PART MISSING FROM THE DISTAL SECTION WAS IMPOSSIBLE TO BE CONFIRMED SINCE THE VICINITY OF THE CUT END HAD BEEN ELONGATED. THE CUT AND CRUSHED PARTS OF THE ACTUAL SAMPLE WERE FURTHER ENLARGED TO CONFIRM THE APPEARANCE. IT WAS FOUND THAT THE INNER LAYER WAS EXPOSED, THE CUT END HAD BEEN CRUSHED, AND THE CRUSHED SECTIONS HAD BEEN TORN AND MISALIGNED RADIALLY. THE CUT AND CRUSHED PARTS OF THE ACTUAL SAMPLE WERE FURTHER ENLARGED TO CONFIRM THE APPEARANCE. IT WAS FOUND THAT THE INNER LAYER WAS EXPOSED, AND THE CUT END HAD BEEN CRUSHED. THE CRUSHED SECTIONS NEAR THE CUT END HAD BEEN TORN AND THE SHAFT HAD BEEN MISALIGNED IN THE RADIAL DIRECTION. THE OUTER DIAMETER OF THE ACTUAL SAMPLE WAS MEASURED AT THE NORMAL SECTION AND CONFIRMED TO MEET THE FACTORY'S CONTROL CRITERIA. NO DIMENSIONAL ANOMALY WAS OBSERVED. SPECIFICATION OF THE CONCURRENTLY USED DEVICE: THE CONCURRENTLY USED DEVICE, PARENT PLUS FROM MEDIKIT, WAS THE CATHETER WITH A STOPCOCK ATTACHED TO THE PROXIMAL SIDE. REPRODUCTIVE TESTING WAS PERFORMED AND A FACTORY-RETAINED PROGREAT WAS COMBINED WITH A GUIDEWIRE, AND THEN INSERTED INTO A FACTORY-RETAINED ANGIOGRAPHIC CATHETER (GLIDECATH, WITH STOPCOCK). NEXT, THE KNOB WAS TURNED 45° TO CLOSE THE STOPCOCK, AND THEN A TENSILE LOAD WAS APPLIED TO THE PROGREAT. THIS MANIPULATION WAS REPEATED AT MULTIPLE POINT OF THE CATHETER. AS A RESULT, CUTTING AND ALMOST EVENLY SPACED CRUSHING WERE GENERATED. MAGNIFYING INSPECTION OF THE CUT END FOUND THAT IT HAD BEEN CRUSHED AND ELONGATED. THE INNER LAYER AND THE REINFORCING WIRE WERE EXPOSED FROM THE CUT END. THE CRUSHED SECTIONS NEAR THE CUT END HAD BEEN TORN AND MISALIGNED. THIS STATE WAS FOUND SIMILAR TO THAT OF THE ACTUAL SAMPLE. INSPECTION OF THE WHITE FIBER: THE APPEARANCE OF THE WHITE FIBER WAS CHECKED VISUALLY. IT WAS FOUND TO BE LIKE FOLDED THREADS. THE WHITE FIBER WAS ANALYZED BY FT-IR. THE IR SPECTRA OF CELLULOSE WERE OBTAINED; HOWEVER, THERE WERE NO PARTS OF CELLULOSE USED IN THIS PRODUCT. NEXT, AMONG THE MATERIALS USED IN THE PRODUCTION PROCESS, THOSE CONTAINING WHITE THREADS WERE SEARCHED. AS A RESULT, TWO TYPES OF GLOVE WERE FOUND TO BE APPLICABLE. HOWEVER, THE SPECTRA OF BOTH GLOVES DIFFERED FROM THAT OF THE WHITE FIBER IN QUESTION. (NOTE: THE FT-IR MEASUREMENT (FOURIER TRANSFORM INFRARED SPECTROSCOPY) IS A TECHNIQUE TO ANALYZE THE SPECTRA OBTAINED BY IRRADIATING INFRARED RAYS TO THE MEASUREMENT TARGET.) IT WAS LIKELY THAT THE WHITE FIBER WAS NOT DERIVED FROM THE ACTUAL SAMPLE OR MANUFACTURING PROCESS. A REVIEW OF THE DEVICE HISTORY RECORD AND THE PRODUCT-RELEASE JUDGEMENT RECORD OF THE INVOLVED PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. BASED ON THE PROVIDED INFORMATION AND INVESTIGATION RESULTS, THERE IS NO DEFINITIVE EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. IT WAS LIKELY THAT THE CUT OF THE SHAFT WAS CAUSED BY THE FOLLOWING MECHANISM: WHEN THE STOPCOCK WAS MANIPULATED WHILE THE ACTUAL SAMPLE WAS INSERTED IN THE CONCURRENTLY USED DEVICE, THE ACTUAL SAMPLE WAS PINCHED BY THE STOPCOCK AND CRUSHED. AS A RESULT, THE LUMEN OF THE ACTUAL SAMPLE BECAME NARROW, PREVENTING THE INSERTION OF THE GUIDEWIRE. SUBSEQUENTLY, THE ACTUAL SAMPLE IN THAT STATE WAS SUBJECTED TO A TENSILE LOAD, THE AREA NEAR THE CRUSHED AREA WAS ELONGATED WITH RESULTANT CUT OF THE SHAFT. IN ADDITION, THE REINFORCING COIL INSIDE THE ACTUAL SAMPLE BECAME EXPOSED FROM THE CUT END. AS FOR THE WHITE FIBER RETURNED ALONG WITH THE ACTUAL SAMPLE, IT WAS CONFIRMED THAT IT DID NOT ORIGINATE FROM THE ACTUAL SAMPLE OR MANUFACTURING PROCESS. THE SOURCE OF THE WHITE FIBER COULD NOT BE CLARIFIED. THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. TERUMO MEDICAL PRODUCTS (TMP) IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. (B)(4).

Description of Event or Problem · 1

THE USER FACILITY REPORTED THAT THE PROGREAT WAS USED PRE-TREATMENT. A HEMOSTATIC VALVE WAS ATTACHED TO A PARENT PLUS 5FR CATHETER FROM MEDIKIT, AND THEN A MEISTER GUIDEWIRE FROM (B)(4) WAS TRIED TO BE INSERTED IN A PROGREAT ALTHOUGH FAILED. WHEN THE PROGREAT WAS CHECKED, A WIRE-LIKE OBJECT CAME OUT FROM IT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS NOT HARMED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
796118	PROGREAT	CATHETER, INTRAVASCULAR, DIAGNOSTIC	DQO		NA	200522

Patients

Seq	Age	Sex	Outcome	Treatment
1