PROGREAT

Report

Report Number: 9681834-2021-00075
Event Type: Injury
Date Received: April 30, 2021
Date of Event: April 15, 2021
Report Date: April 30, 2021
Product Code: DQO
PMA / PMN Number: K033583
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

UDI - NOT REQUIRED FOR PRODUCT CODE. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. PMA/510(K)- K033913, K170223. THE ACTUALS SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT IT HAD BEEN FRACTURED AT APPROX. 134MM FROM THE DISTAL END. A CRUSH WAS OBSERVED NEAR THE FRACTURE, AT APPROXIMATELY 128 MM FROM THE DISTAL END. THE DISTANCE BETWEEN THE FRACTURE END AND THE CRUSH WAS APPROXIMATELY 6 MM. THE TOTAL LENGTH OF THE ACTUAL SAMPLE WAS APPROXIMATELY 1303 MM (DISTAL PORTION: APPROXIMATELY 134 MM, THE MAIN BODY: APPROXIMATELY 1169 MM). COMPARED TO THE EFFECTIVE LENGTH OF THIS PRODUCT T CODE, WHICH IS APPROXIMATELY 1300 MM, IT WAS CONCEIVABLE THAT THERE WAS NO DEFICIENT PORTION IN THE ACTUAL SAMPLE. MAGNIFYING INSPECTION OF THE FRACTURED SECTION FOUND THAT THE SHAFT HAD BEEN CRUSHED AND MISALIGNED AT APPROX. 128 MM FROM THE DISTAL END. THE FRACTURE END OF THE SHAFT HAD BEEN ELONGATED, AND THE INNER LAYER AND THE STAINLESS-STEEL REINFORCEMENT WERE EXPOSED FROM THE FRACTURE END. THE OUTER DIAMETER WAS MEASURED ON THE UNDAMAGED AREA AND CONFIRMED TO MEET THE FACTORY'S CONTROL CRITERIA. NO ANOMALY WAS NOTED IN THE OUTER DIAMETER. SPECIFICATION OF THE CONCURRENTLY USED DEVICE: THE CONCURRENTLY USED DEVICE, SHEPHERD HOOK TYPE CATHETER FROM MEDIKIT CO., 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. AS A RESULT, THE PROGREAT WAS FRACTURED. MAGNIFYING INSPECTION OF THE FRACTURED SECTION FOUND THAT THE SHAFT HAD BEEN CRUSHED AND MISALIGNED AT APPROXIMATELY 128 MM FROM THE DISTAL END (THE DISTANCE BETWEEN THE FRACTURE END AND THE CRUSH WAS ABOUT 6 MM). THE FRACTURE END OF THE SHAFT HAD BEEN ELONGATED, AND THE INNER LAYER AND THE STAINLESS-STEEL REINFORCEMENT WERE EXPOSED FROM THE FRACTURE END. THIS STATE WAS SIMILAR TO THAT OF THE ACTUAL SAMPLE. A REVIEW OF THE DEVICE HISTORY RECORD AND THE SHIPPING INSPECTION 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 IS LIKELY THAT AFTER THE ACTUAL SAMPLE WAS INSERTED INTO THE CONCURRENTLY USED DEVICE, THE STOPCOCK WAS OPERATED, AS A RESULT, THE ACTUAL SAMPLE WAS CAUGHT IN THE STOPCOCK. IN THE CAUGHT STATE, THE ACTUAL SAMPLE WAS SUBJECTED TO A TENSILE LOAD, WHICH LED TO THE FRACTURE. HOWEVER, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. (B)(4).

Description of Event or Problem · 1

THE USER FACILITY REPORTED THAT THE INVOLVED PROGREAT WAS USED DURING THE PROCEDURE. RESISTANCE WAS FELT WITH GUIDEWIRE DURING INSERTION INTO PARENT CATHETER. AFTER REPLACING THE GUIDEWIRE WITH THE SECOND ONE, WHEN THEY TRIED TO PASS THROUGH, THE MICRO CATHETER WAS FRACTURED. THERE WAS A POSSIBILITY THAT THE MICRO CATHETER WAS CRUSHED BY THE Y-CONNECTOR DURING THE PROCEDURE. THE FRACTURED PORTION WAS RECOVERED WITH EN SNARE. THE PROCEDURE WAS CONTINUED WITH BETA 3 AND COMPLETED SUCCESSFULLY. THE PATIENT WAS NOT HARMED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
652067	PROGREAT	CATHETER, INTRAVASCULAR, DIAGNOSTIC	DQO		NA	200604

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention