ASAHI SION
Report
- Report Number
- 3003775027-2023-00121
- Event Type
- Injury
- Date Received
- November 22, 2023
- Date of Event
- October 25, 2023
- Report Date
- July 22, 2024
- Manufacturer
- ASAHI INTECC CO., LTD.
- Product Code
- DQX
- PMA / PMN Number
- K191464
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
**UDI RELATED DATA QUALITY UPDATES ONLY** AS WE RECEIVED AN EMAIL TIME-STAMPED SATURDAY, (B)(6) 2024 9:54 AM AT OUR END FROM (B)(6), MDR DATA SYSTEMS TEAM, TO INFORM US THAT INFORMATION ABOUT THE SUSPECT MEDICAL DEVICES INVOLVED IN THE REPORTED EVENTS, SPECIFICALLY THE UNIQUE DEVICE IDENTIFIER (UDI) INFORMATION IN SECTION D OF THE FDA FORM 3500A WAS MISSING. AFTER COMPARING THE INFORMATION IN THE PREVIOUS SUBMITTED MDR WITH THAT OF ASAHI SION IN THE CORRESPONDING FIELDS IN THE GUDID, WE DETERMINED TO SUBMIT THIS SUPPLEMENTAL REPORT. THE CHANGES WE INTEND TO MAKE ARE AS FOLLOWS: D1: BRAND NAME - FROM SION TO ASAHI SION D3: MANUFACTURER NAME, CITY, AND STATE - FROM ASAHI INTECC CO., LTD. TO ASAHI INTECC CO., LTD. D4: MODEL # - FROM NA TO NO ENTRY CATALOG # - FROM UNKNOWN TO NO ENTRY SERIAL # - FROM NA TO NO ENTRY LOT # - FROM UNKNOWN TO NO ENTRY PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) # - FROM UNKNOWN TO NO ENTRY G1: CONTACT OFFICE - FROM ASAHI INTECC CO., LTD. TO ASAHI INTECC CO., LTD. EMAIL - FROM [email protected] TO [email protected] AS LOT INFORMATION WAS UNAVAILABLE, THE PRODUCT LABEL INCLUDED IN THE PRODUCTION RECORD, WHICH IS LINKED TO THE LOT INFORMATION, COULD NOT BE CONFIRMED. THEREFORE, THE UNIQUE DEVICE IDENTIFIER (UDI) #, MODEL # AND EXPIRATION DATE COULD NOT BE OBTAINED.
MANUFACTURING SITE: MANUFACTURING SITE COULD NOT BE IDENTIFIED BECAUSE THE PRODUCT LOT NUMBER INFORMATION WAS NOT AVAILABLE. THE OUTER COIL OF THE RETURNED SION GUIDE WIRE WAS FOUND ELONGATED AND FRACTURED FOR APPROXIMATELY 160MM FROM THE DISTAL-MID SOLDER (SET AT 25MM FROM THE TIP). THE INNER COIL UNDERNEATH WAS EXPOSED. AT APPROXIMATELY 18MM DISTAL TO THE DISTAL-MID SOLDER, THE CORE WIRE AS WELL AS THE UNRAVELED AND ELONGATED TWIST WIRE WERE FOUND FRACTURE. OBSERVATION BY SCANNING ELECTRON MICROSCOPE (SEM) FOUND THAT THE FRACTURE END OF THE CORE WIRE WAS TWISTED AND HAD A RELATIVELY FLAT FRACTURE SURFACE, INDICATING THAT TORSION HAD CONTRIBUTED TO THE CORE WIRE FRACTURE. THE FRACTURE END OF THE TWIST WIRE WAS FOUND NECKED, WHICH IS A TRACE OF DUCTILE FRACTURE. THE FRACTURE END OF THE OUTER COIL WAS TWISTED AND HAD A RELATIVELY FLAT FRACTURE SURFACE, INFERRING THAT THE OUTER COIL FRACTURE WAS ATTRIBUTED TO TORSION GENERATED MOST LIKELY WHEN THE OUTER COIL WAS PULLED AND STRAIGHTENED. INVESTIGATION OF THE RETURNED GUIDE WIRE SUGGESTED THAT APPROXIMATELY 6MM OF THE WIRE TIP WAS MISSING. LOT HISTORY RECORDS REVIEW COULD NOT BE CONDUCTED BECAUSE LOT INFORMATION WAS UNAVAILABLE. ALL THE SHIPPED PRODUCTS WERE INSPECTED IN THE PRODUCTION PROCESS AND SATISFIED THE PRODUCT SPECIFICATIONS AND RELEASE CRITERIA; THEREFORE, IT WAS CONCLUDED THAT THERE WAS NO ANOMALY IN PRODUCT QUALITY. BASED ON THE OBTAINED INFORMATION AND THE ABOVE INVESTIGATION OUTCOME, IT WAS PRESUMED THAT TORSION GENERATED WITH TORQUING MANIPULATION MIGHT HAVE BEEN LOCALLY ACCUMULATED ON THE CORE WIRE OF THE SION GUIDE WIRE WHILE THE WIRE TIP WAS CAUGHT BY THE STENT STRUT. CONSEQUENTLY, THE CORE WIRE WAS FRACTURED. FURTHER APPLIED TENSILE STRESS GENERATED WITH REMOVAL THEN MADE THE TWIST WIRE AND THE OUTER COIL ELONGATE TO FRACTURE. IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTED TO PRODUCT QUALITY. NO CAPA WILL BE TAKEN. INSTRUCTIONS FOR USE (IFU) STATES: [WARNINGS] ~ OBSERVE MOVEMENT OF THIS GUIDE WIRE IN THE VESSELS. BEFORE THIS GUIDE WIRE IS MOVED OR TORQUED, THE TIP MOVEMENT SHOULD BE EXAMINED AND MONITORED UNDER FLUOROSCOPY. DO NOT MOVE OR TORQUE THE GUIDE WIRE WITHOUT OBSERVING CORRESPONDING MOVEMENT OF THE TIP; OTHERWISE, THE GUIDE WIRE MAY BE DAMAGED AND/OR TRAUMA MAY OCCUR. IN ADDITION, ENSURE THAT THE DISTAL TIP OF THIS GUIDE WIRE AND ITS LOCATION IN THE VESSEL ARE VISIBLE DURING MANIPULATIONS OF THE GUIDE WIRE. ~ NEVER PUSH, AUGER, WITHDRAW, OR TORQUE THIS GUIDE WIRE THAT MEETS RESISTANCE. TORQUING OR PUSHING THIS GUIDE WIRE AGAINST RESISTANCE MAY CAUSE DAMAGE AND/OR TIP SEPARATION OF THIS GUIDE WIRE OR DIRECT DAMAGE TO A VESSEL. RESISTANCE MAY BE FELT AND/OR OBSERVED UNDER FLUOROSCOPY BY NOTING ANY BUCKLING OF THE GUIDE WIRE. IF THE PROLAPSE OF THE GUIDE WIRE TIP IS OBSERVED, DO NOT ALLOW THE TIP TO REMAIN IN A PROLAPSED POSITION; OTHERWISE DAMAGE TO THE GUIDE WIRE MAY OCCUR. DETERMINE THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY AND TAKE ANY NECESSARY REMEDIAL ACTION. ~ IF RESISTANCE IS FELT DUE TO SPASM, BENDING OF THE GUIDE WIRE, OR DUE TO TRAP WHILE OPERATING THIS GUIDE WIRE IN THE BLOOD VESSEL OR REMOVING IT, DO NOT TORQUE AND/OR PULL THE GUIDE WIRE ITSELF. STOP THE PROCEDURE. DETERMINE THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY AND TAKE APPROPRIATE REMEDIAL ACTION. IF THE GUIDE WIRE IS MOVED EXCESSIVELY, IT MAY BREAK OR BECOME DAMAGED, WHICH MAY CAUSE BLOOD VESSEL INJURY OR RESULT IN FRAGMENTS BEING LEFT INSIDE THE VESSEL. ~ WHEN TORQUING THIS GUIDE WIRE INSIDE THE BLOOD VESSEL, DO NOT TORQUE CONTINUOUSLY IN THE SAME DIRECTION. THIS MAY CAUSE THE GUIDE WIRE TO BECOME DAMAGED OR BREAK APART, CAUSING INJURY TO THE BLOOD VESSEL OR LEAVING FRAGMENTS INSIDE THE VESSEL. WHEN TORQUING THE GUIDE WIRE, ROTATE IT CLOCKWISE AND COUNTERCLOCKWISE ALTERNATELY. DO NOT EXCEED TWO ROTATIONS (720 DEGREES) IN THE SAME DIRECTION. [MALFUNCTION AND ADVERSE EFFECTS] ~ SEPARATION OF THE GUIDE WIRE.
IT WAS REPORTED THAT THE TIP OF AN ASAHI SION GUIDE WIRE HAD FRACTURED DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) TO TREAT A MODERATELY TORTUOUS, HEAVILY CALCIFIED CHRONIC TOTAL OCCLUSION (CTO) IN THE MID-DISTAL LEFT CIRCUMFLEX ARTERY (LCX). DURING POST-DILATATION OF THE STENT, THE SION GUIDE WIRE WAS FOUND DEFORMED INTO A KNUCKLE-LIKE SHAPE AND GOT STUCK IN THE STENT STRUT. WHEN REMOVED, THE SION WAS FOUND FRACTURED AT ABOUT 1CM FROM THE TIP AND THE SEPARATED WIRE TIP REMAINED IN THE PATIENT ANATOMY. RETRIEVAL WITH MICRO SNARE OR ADDITIONAL STENT DEPLOYMENT WAS ALSO CONSIDERED. BASED ON THE PHYSICIAN'S JUDGMENT, THE PATIENT WILL BE UNDERGOING MEDICATION FOR A MONTH AND MONITORED AS A CONSERVATION TREATMENT. IT WAS INFORMED THAT THE PATIENT WAS FINE WITHOUT ANY COMPLICATIONS AFTER THE PROCEDURE AND THE BLOOD FLOW WAS GOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1668832 | ASAHI SION | PTCA GUIDE WIRE | DQX | ASAHI INTECC CO., LTD. | NA | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Disability |