GLIDESHEATH

Report

Report Number: 9681834-2022-00220
Event Type: Malfunction
Date Received: November 1, 2022
Date of Event: October 4, 2022
Report Date: November 1, 2022
Manufacturer: TERUMO CORPORATION, ASHITAKA
Product Code: DYB
PMA / PMN Number: K033681
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. PMA/510(K): K033681, K062858, K082644. THE ACTUAL DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE ACTUAL SAMPLE UPON RECEIPT WAS ONLY A MINI GUIDEWIRE. VISUAL INSPECTION OBTAINED FOLLOWING RESULTS: (I) IT WAS DIVIDED INTO A FRACTURED PIECE AND A MAIN BODY PART; (II) THE WIRE HAD BEEN EXPOSED AT THE DISTAL END OF MAIN BODY; (III) THE DIMENSIONS WERE AS FOLLOWS; (I) FRACTURED PIECE WAS APPROXIMATELY 10MM; (II) THE MAIN BODY WIRE EXPOSED PART WAS APPROXIMATELY 2MM; (II) TOTAL LENGTH APPROXIMATELY 794MM. X-RAY FLUOROSCOPIC INSPECTION OF THE FRACTURED PIECE FOUND THAT THE WIRE HAD BEEN REMAINED INSIDE THE URETHANE, AND THE FRACTURED SECTION OF WIRE WAS AT APPROXIMATELY 6MM FROM THE DISTAL END. SINCE THE TOTAL LENGTH WAS APPROXIMATELY 800MM WHEN THE FRACTURED PIECE AND THE FRACTURED SECTION OF THE MAIN BODY OF WIRE WERE ALIGNED, IT WAS LIKELY THAT THERE WAS NO MISSING. MAGNIFYING INSPECTION OF EACH FRACTURED PIECE AND MAIN BODY OBTAINED FOLLOWING RESULTS FOR THE FRACTURED PIECE: (I) IT HAD BEEN ELONGATED AT APPROXIMATELY 6MM FROM THE DISTAL END; (II) THE FRACTURED SECTION HAD BEEN FLATTENED. FOR THE MAIN BODY: (I) NO TAPERING WAS FOUND AT THE DISTAL END OF WIRE; (II) IT HAD BEEN SCRATCHED AT APPROX. 5MM FROM THE DISTAL END. ELECTRON MICROSCOPIC INSPECTION OF EACH FRACTURED PIECE AND MAIN BODY OBTAINED FOLLOWING RESULTS FOR THE FRACTURED PIECE WAS A TORN AND FOR THE TOP SURFACE OF WIRE RADIAL PATTERNS WERE FOUND. THE OUTER DIAMETER OF ACTUAL SAMPLE WAS MEASURED AND CONFIRMED TO MEET THE SPECIFICATIONS. REVIEW OF THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE INVOLVED PRODUCT CODE/LOT NUMBER COMBINATION CONFIRMED THAT THERE WERE NOT ANY INDICATIONS OF ANOMALY IN THEM. A SEARCH OF THE COMPLAINT FILE FOUND NO OTHER SIMILAR REPORT WITH THE INVOLVED PRODUCT CODE/LOT NUMBER COMBINATION FROM OTHER FACILITIES. BASED ON OUR PAST KNOWLEDGE, THE FOLLOWING SIMULATION TEST WAS PERFORMED FOR THE FRACTURE OF MINI GUIDEWIRE. FROM THE TEST RESULT, WE HAVE BEEN AWARE THAT THERE WAS REGULARITY IN THE WIRE STATE DEPENDING ON THE MECHANISM LEADING TO FRACTURE. WHEN THE MINI GUIDEWIRE WAS FRACTURED BY APPLYING CONTINUOUS TORQUE FORCE IN THE SAME DIRECTION WHILE IT WAS CURVED. NO TAPER WAS FOUND ON THE SIDE SURFACE OF WIRE AT THE FRACTURED SECTION, AND RADIAL PATTERNS WERE FOUND ON THE FRACTURED SURFACE OF WIRE. FROM THIS RESULT, IT WAS INFERRED THAT IT WAS LIKE THE CONDITION OF ACTUAL SAMPLE. WHEN IT WAS FRACTURED BY APPLYING REPEATED 90° BENDING FORCE. NO TAPER WAS FOUND ON THE SIDE SURFACE OF WIRE AT THE FRACTURED SECTION, AND DIMPLE PATTERN (A HOLE-SHAPED PATTERN) WAS FOUND ON THE FRACTURED SURFACE OF WIRE. FROM THIS RESULT, IT WAS INFERRED THAT THE OCCURRENCE MECHANISM WAS DIFFERENT FROM THAT OF THE ACTUAL SAMPLE. WHEN IT WAS FRACTURED BY APPLYING PULLING FORCE. THE SIDE SURFACE OF WIRE AT THE FRACTURED SECTION WAS TAPERED. FROM THIS RESULT, IT WAS INFERRED THAT THE OCCURRENCE MECHANISM WAS DIFFERENT FROM THAT OF THE ACTUAL SAMPLE. WHEN IT WAS FRACTURED BY APPLYING PULLING FORCE IN A LOOPED STATE. THE SIDE SURFACE OF WIRE AT THE FRACTURED SECTION WAS TAPERED AND CURVED. FROM THIS RESULT, IT WAS INFERRED THAT THE OCCURRENCE MECHANISM WAS DIFFERENT FROM THAT OF THE ACTUAL SAMPLE. BASED ON THE INVESTIGATION RESULT AND THE SIMULATION TEST RESULT, IT WAS LIKELY THAT CONTINUOUS TORQUE OPERATION WAS PERFORMED IN A CURVED OR STUCK STATE, AND WIRE WAS FRACTURED DUE TO METAL FATIGUE. THEN, PULLING FORCE WAS APPLIED WHEN IT WAS PULLED TO THE HAND SIDE, AND THE OUTER LAYER WAS FRACTURED. IN ADDITION, SINCE THE TOTAL LENGTH OF ACTUAL SAMPLE INCLUDING THE FRACTURED PIECE WAS EQUIVALENT TO THE NORMAL PRODUCT, IT WAS INFERRED THAT THERE WAS NO MISSING PIECE. RELEVANT IFU (INSTRUCTIONS FOR USE) REFERENCE: "PRECAUTIONS. THE MINI GUIDE WIRE IN THIS KIT IS DESIGNED TO BE USED ONLY FOR SHEATH INSERTION. USAGE FOR ANY OTHER PURPOSE MAY RESULT IN DAMAGE TO AND/OR SEPARATION OF THE WIRE, WHICH MAY HAVE TO BE REMOVED FROM THE VESSEL." (B)(4).

Description of Event or Problem · 0

THE USER FACILITY REPORTED THAT THE INVOLVED PRODUCT WAS USED WHEN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) (FOR SHUNT) WAS PERFORMED. THE TARGET SITE WAS OCCLUDED AND HAD NUMEROUS SIDE BRANCHES IN ADDITION TO THE MAIN VESSEL. AN ATTEMPT WAS MADE TO PASS THROUGH THE OCCLUSION USING THE INVOLVED MINI GUIDEWIRE AND IT ENTERED A SIDE BRANCH. WHEN ATTEMPTED TO PULL IT TO THE HAND SIDE TO RETURN IT, A DEFECT WAS NOTICED IN THE DISTAL PART UNDER ANGIOGRAPHY. THEN, WHEN THE MINI GUIDEWIRE WAS REMOVED, IT WAS FOUND THAT THE DISTAL SIDE AND THE SHAFT PART WERE FRACTURED. WHEN THE MINI GUIDEWIRE WAS REMOVED, IT SEEMED TO BE CONNECTED ONLY AT THE SURFACE LAYER, AND IT WAS THOUGHT THAT THERE WAS NO FRACTURED PIECE REMAINED IN THE PATIENT'S BODY. THE PROCEDURE WAS PERFORMED USING ANOTHER MINI GUIDEWIRE. THEY UNDERSTOOD THAT THE INVOLVED MINI GUIDEWIRE SHOULD NOT BE USED AS A SHUNT PTA WIRE. DUE TO INSURANCE REASONS, IN CASES LIKE THIS EVENT (PTA FOR SHUNT), THE INVOLVED PRODUCT IS USED INSTEAD OF A THERAPEUTIC WIRE. TORQUE WAS APPLIED DURING WIRE OPERATION. THE EVENT OCCURRED INTRA-OPERATIVE. THE PATIENT WAS NOT INJURED DURING THE EVENT AND MEDICAL OR SURGICAL INTERVENTION WAS NOT REQUIRED. THE PATIENT'S FINAL IMPACT WAS NOT HARMED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1124869	GLIDESHEATH	INTRODUCER, CATHETER	DYB	TERUMO CORPORATION, ASHITAKA	N/A	220204

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown