ULTIMATEBROS 3
Report
- Report Number
- 3003775027-2023-00131
- Event Type
- Injury
- Date Received
- December 20, 2023
- Date of Event
- November 27, 2023
- Report Date
- July 19, 2024
- Manufacturer
- ASAHI INTECC CO., LTD.
- Product Code
- DQX
- UDI-DI
- 04547327083737
- PMA / PMN Number
- K171933
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
**UDI RELATED DATA QUALITY UPDATES ONLY** AS WE RECEIVED AN EMAIL, TIME-STAMPED SATURDAY, JULY 6, 2024 1:27 AM AT OUR END FROM (B)(6), MDR DATA SYSTEMS TEAM. TO INFORM US OF THE DISCREPANCIES IN THE DEVICE IDENTIFICATION FIELDS OF OUR SUBMITTED ELECTRONIC EQUIVALENT OF THE FDA FORM 3500A. WHEN COMPARED WITH THE INFORMATION IN THE GUDID. AFTER COMPARING THE INFORMATION IN THE PREVIOUS SUBMITTED MDR WITH THAT IN THE CORRESPONDING FIELDS IN THE GUDID. WE DETERMINED, TO SUBMIT THIS SUPPLEMENTAL REPORT. THE CHANGES WE INTEND TO MAKE ARE AS FOLLOWS: D3: MANUFACTURER NAME, CITY AND STATE: FROM ASAHI INTECC CO., LTD. TO ASAHI INTECC CO., LTD. D4: MODEL #: FROM NO ENTRY TO AHW14S003S. CATALOG #: FROM AHW14S003S TO NO ENTRY. G1: CONTACT OFFICE: FROM ASAHI INTECC CO., LTD. TO ASAHI INTECC CO., LTD. H4: DEVICE MANUFACTURE DATE: FROM 12-4-2022 TO NO ENTRY.
MANUFACTURING SITE: ASAHI INTECC HANOI CO., LTD. HANOI, VIETNAM, REGISTRATION NUMBER: 3009121749 THE REPORTED ULTIMATEBROS 3 GUIDE WIRE WAS RETURNED FOR EVALUATION WITH THE CONCOMITANTLY USED TURNPIKE LP CATHETER. THE DISTAL SEGMENT OF THE ULTIMATEBROS 3 GUIDE WIRE WAS FOUND OUT OF THE CATHETER TIP FOR APPROXIMATELY 620MM. ORIGINATING FROM THE PROXIMAL SOLDER OF THE GUIDE WIRE (SET AT 120MM FROM THE WIRE TIP FOR THE PURPOSE OF FIXING THE OUTER COIL ONTO THE CORE), THE OUTER COIL WAS FOUND STRETCHED FOR APPROXIMATELY 105MM AND THEN FRACTURED. THE CORE OF GUIDE WIRE WAS FRACTURED AT APPROXIMATELY 90MM DISTAL TO THE PROXIMAL SOLDER. MICROSCOPIC OBSERVATION OF THE FRACTURE END OF OUTER COIL FOUND THAT THE OUTER COIL WAS TWISTED PROXIMAL TO THE FRACTURE END THAT WAS NECKED BY TENSILE STRESS. THESE FINDINGS INDICATED THAT TORSION GENERATED WHEN THE OUTER COIL WAS STRAIGHTENED HAD CONTRIBUTED THE OUTER COIL TO BECOME TWISTED AND TENSILE STRESS HAD CAUSED THE SEPARATION OF THE OUTER COIL. MICROSCOPIC OBSERVATION OF THE FRACTURE END OF THE CORE FOUND A FLAT FRACTURE SURFACE AND HELICAL MARKS ON THE CORE SHAFT, INDICATING THAT ACCUMULATED TORSION HAD CONTRIBUTED TO THE CORE FRACTURE. MEASUREMENT OF THE RETURNED GUIDE WIRE FOUND THAT THE OUTER COIL WAS FRACTURED AT APPROXIMATELY 100MM FROM THE TIP AND THE CORE WAS FRACTURED AT APPROXIMATELY 30MM FROM THE TIP. LOT HISTORY REVIEW REVEALED NO ANOMALY RELATING TO THE REPORTED EVENT. NO OTHER SIMILAR PRODUCT EXPERIENCE REPORT WAS RECEIVED FROM THIS LOT. BASED ON THE OBTAINED INFORMATION AND THE INVESTIGATION OUTCOME, IT WAS PRESUMED THAT TORSION GENERATED WITH TORQUING MANIPULATION WAS LOCALLY ACCUMULATED ON THE ULTIMATEBROS 3 GUIDE WIRE LIKELY WHEN THE WIRE TIP WAS CAUGHT BY THE CTO, FRACTURING THE CORE. FURTHER APPLIED TENSILE STRESS GENERATED WITH REMOVAL THEN MADE THE OUTER COIL STRETCH 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. ~ IF RESISTANCE IS FELT BETWEEN THIS GUIDE WIRE AND THE OTHER INTERVENTIONAL DEVICES WHILE OPERATING THIS GUIDE WIRE IN THE BLOOD VESSEL, AVOID APPLYING EXCESSIVE FORCE. WHEN ABNORMAL RESISTANCE IS FELT, REMOVE THE ENTIRE SYSTEM FROM THE PATIENT'S BODY AND DETERMINE THE CAUSE. OTHERWISE, THE GUIDE WIRE MAY BREAK OR BE DAMAGED AND MAY CAUSE INJURY TO THE BLOOD VESSEL OR LEAVE FRAGMENTS 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 ULTIMATEBROS 3 GUIDE WIRE HAD FRACTURED DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) TO TREAT A HEAVILY CALCIFIED CHRONIC TOTAL OCCLUSION (CTO) IN THE RIGHT CORONARY ARTERY (RCA). WHEN THE ULTIMATEBROS 3 GUIDE WIRE WAS USED WITH A NON-ASAHI TURNPIKE LP MICROCATHETER TO CROSS THE LESION, THE GUIDE WIRE GOT STUCK IN THE TURNPIKE LP CATHETER. WHEN ATTEMPTS WERE MADE TO REMOVE THE ULTIMATEBROS 3 GUIDE WIRE, IT BROKE OFF. THE COIL OF THE WIRE FRAGMENT WAS UNRAVELED AND REACHED THE ABDOMINAL AORTA. BECAUSE OF THE WIRE FRAGMENT AND A SIGNIFICANT STENOSIS IN AN UNSPECIFIED DIAGONAL ARTERY OF THE LEFT ANTERIOR DESCENDING ARTERY (LAD), CORONARY ARTERY BYPASS GRAFTING (CABG) WAS PERFORMED TO SUCCESSFULLY REMOVE THE WIRE FRAGMENT AND REESTABLISH BLOOD FLOW. IT WAS INFORMED THAT THE OUTCOME OF THE CABG WAS GOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2109575 | ULTIMATEBROS 3 | PTCA GUIDE WIRE | DQX | ASAHI INTECC CO., LTD. | AHW14S003S | 220324A77A | 04547327083737 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other| R |