MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. CONFIANZA PRO 12; PTCA GUIDE WIRE

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Hematoma (1884)

Event Type  Injury  

Manufacturer Narrative

Manufacturing site: manufacturing site could not be identified because the product lot number information was not available.Device evaluation could not be performed because the affected device was not returned.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.Multiple products were used in the procedure; however, how each mentioned product had caused or contributed to hematoma formation or possible vessel dissection was unable to be determined based on the limited written information.Referring to known similar events, it was presumed that patient anatomy and procedural contents were most likely associated with this event.As to detachment of the confianza pro 12 guide wire, it was unable to determine the cause due to limited information regarding how it was used during the procedure.Referring to known similar events, it was presumed that stress generated with manipulation in attempts to cross the lesion had likely contributed to separation of the guide wire.The applied stress would exceed the product design limit mostly when the wire tip was being trapped or restricted its movement by the lesion.It was concluded that this event was not attributed to product quality.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.[malfunctions and adverse effects] vessel dissection.

Event Description

It was reported through a research article titled "feasibility of 5 fr contralateral radial access for hybrid chronic total occlusion percutaneous coronary intervention: experience from a single tertiary center in the (b)(6) (the journal of invasive cardiology 2019;31(6):159-165)" that identified an asahi confianza pro 12 guide wire had separated during a percutaneous coronary intervention (pci) specified as case #3.Excerpt is as follows: a (b)(6) year-old man with a background of bronchiectasis and metastatic renal cell carcinoma presented for elective cto-pci of his rca (j-cto score, 3).He had ongoing limiting stable angina despite 3 antianginal medications and significant dyspnea.Five fr access was gained via the right and left radial arteries.The 5 fr left radial access was exchanged for a 7.5 fr sheathless al 0.75 guide to engage the rca.A 5 fr ebu 4.0 guide engaged the lca via the right radial sheath.An attempt at antegrade wire escalation and adr failed; therefore, a retrograde approach was adopted.An attempt at retrograde access via lad septals was also unsuccessful, so a retrograde attempt was made via an epicardial collateral from the lcx via the atrioventricular groove branch to the posterior left ventricular (plv) artery using a sion wire (asahi intecc).A turnpike lp microcatheter (aquailant interventional) would not pass, but its retrograde path was facilitated by knuckling an antegrade wire to perform balloon trapping of the retrograde wire with an antegrade balloon.A distal hematoma occurred as a consequence, with the loss of a small posterior descending artery.During retrograde wiring, the tip of a retrograde confianza pro 12 wire became detached in the vessel.A subsequent pilot 200 wire (abbott) was then used to perform a reverse-cart procedure, which was challenging due to a large subintimal space.This then allowed pci with 4 drug-eluting stents from the plv back to the proximal rca, which resulted in timi 3 flow at completion.

• Brand Name: CONFIANZA PRO 12
• Type of Device: PTCA GUIDE WIRE
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• Manufacturer (Section G): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• Manufacturer Contact: yukako homma ; 3-100 akatsuki-cho; seto, aichi 489-0-071 ; JA 489-0071
• MDR Report Key: 11326739
• MDR Text Key: 240422076
• Report Number: 3003775027-2021-00031
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K171933
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2021
• Initial Date FDA Received: 02/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 77 YR