ULTIMATEBROS 3
Report
- Report Number
- 3003775027-2023-00120
- Event Type
- Injury
- Date Received
- November 21, 2023
- Date of Event
- October 30, 2023
- Report Date
- July 18, 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 MR. (B)(6), MDR DATA SYSTEMS TEAM, TO INFORM US OF THE DISCREPANCIES BETWEEN THE DEVICE IDENTIFICATION FIELDS OF THE ELECTRONIC EQUIVALENT OF THE FDA FORM 3500A THAT WE HAD SUBMITTED COMPARED TO THE INFORMATION INCLUDED FOR THE CORRESPONDING FIELDS 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 INVESTIGATION. THE CORE OF THE RETURNED ULTIMATEBROS 3 GUIDE WIRE WAS FOUND FRACTURED AT APPROXIMATELY 95MM DISTAL TO THE PROXIMAL SOLDER (SET AT 120MM FROM THE TIP FOR THE PURPOSE OF FIXING THE OUTER COIL ONTO THE CORE). THE OUTER COIL WAS FOUND FRACTURED AT APPROXIMATELY 16MM DISTAL TO THE PROXIMAL SOLDER. MICROSCOPIC OBSERVATION FOUND THAT THE FRACTURE END OF THE OUTER COIL WAS TWISTED AND HAD A FLAT FRACTURE SURFACE, INDICATING THAT THE OUTER COIL WAS FRACTURED DUE TO TORSION GENERATED MOST LIKELY WHEN THE OUTER COIL WAS PULLED AND STRAIGHTENED. MICROSCOPIC OBSERVATION FOUND THAT THE FRACTURE END OF THE CORE WAS TWISTED AND HAD A RELATIVELY FLAT FRACTURE SURFACE AND HELICAL MARKS ON THE SHAFT, SUGGESTING THAT THE CORE WAS FRACTURED DUE TO ACCUMULATED TORSION GENERATED WITH GUIDE WIRE MANIPULATION. MEASUREMENT OF THE RETURNED ULTIMATEBROS 3 GUIDE WIRE SUGGESTED THAT THE CORE WAS FRACTURED AT APPROXIMATELY 25MM FROM THE TIP AND THE OUTER COIL WAS FRACTURED AND DETACHED AT APPROXIMATELY 104MM 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 INVESTIGATION OUTCOME, IT WAS PRESUMED THAT THE TIP SEGMENT OF THE CONCOMITANTLY USED CORSAIR MIGHT HAVE BEEN TWISTED AS TORSION GENERATED WITH CATHETER MANIPULATION WAS LOCALLY ACCUMULATED WHILE THE CATHETER TIP WAS CAUGHT BY THE CTO, CAUSING THE SUBJECT ULTIMATEBROS 3 GUIDE WIRE AND THE CONCOMITANT CORSAIR MICROCATEHTER TO GET STUCK TO EACH OTHER. AS TORSION WAS FURTHER APPLIED ON THE MICROCATHETER, THE GUIDE WIRE WAS ROTATED WITH THE MICROCATHETER, ACCUMULATING TORSION ON THE DISTAL SEGMENT OF THE GUIDE WIRE AND FRACTURING THE CORE. FURTHER APPLIED TENSILE STRESS GENERATED WITH REMOVAL CONSEQUENTLY MADE THE OUTER COIL ELONGATED AND FRACTURED, EVENTUALLY DETACHING THE DISTAL SEGMENT OF THE GUIDE WIRE. IT WAS CONCLUDED THAT THIS EVENT WAS NOT ATTRIBUTED TO PRODUCT QUALITY. CAPA: NO CAPA WILL BE TAKEN. THE 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. [MALFUNCTION AND ADVERSE EFFECTS] SEPARATION OF THE GUIDE WIRE.
IT WAS REPORTED THAT AN ASAHI ULTIMATEBROS 3 GUIDE WIRE AND AN ASAHI CORSAIR MICROCATHETER WERE USED DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) FOR A HEAVILY CALCIFIED CHRONIC TOTAL OCCLUSION (CTO) IN THE RIGHT CORONARY ARTERY (RCA). THE ULTIMATEBROS 3 GUIDE WIRE CROSSED THE CTO WITHOUT RESISTANCE. WHEN AN ATTEMPT WAS MADE TO CROSS THE CTO BY ROTATING THE CORSAIR MICROCATHETER, RESISTANCE WAS MET AND A PART OF THE ULTIMATEBROS 3 GUIDE WIRE WAS FRACTURED IN THE CATHETER TIP. SEVERAL ATTEMPTS WERE MADE TO RETRIEVE THE FRAGMENT BUT FAILED. IT WAS INFORMED THAT THE PATIENT WAS STABLE AND CONSERVATIVELY TREATED BUT SURGICAL TREATMENT MIGHT BE CONSIDERED SHOULD THE PATIENT CONDITION DETERIORATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1992285 | ULTIMATEBROS 3 | PTCA GUIDE WIRE | DQX | ASAHI INTECC CO., LTD. | AHW14S003S | 220324A75A | 04547327083737 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Disability |