MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. REGALIA XS 1.0; PERIPHERAL GUIDE WIRE

Catalog Number PAGP140300R

Device Problem Peeled/Delaminated (1454)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/20/2023

Event Type  Injury  

Event Description

It was reported that a percutaneous peripheral intervention (ppi) was performed to treat a heavily calcified occlusive lesion in the anterior tibial artery (ata).When an asahi regalia xs 1.0 guide wire was used with an asahi corsair armet microcatheter, strong resistance was met.After removal, polymer jacket on the distal segment of the regalia xs 1.0 guide wire was found damaged.When the corsair armet microcatheter was flushed outside the patient anatomy, foreign object(s) was/were found coming out, which was/were likely to be the polymer jacket of the regalia xs 1.0 guide wire.No additional action was taken against this event.The guide wire was then replaced to resume the procedure.Plain old balloon angioplasty (poba) was performed to successfully reestablish blood flow.It was informed that there were no adverse patient effects associated with this event and the patient was fine without any issues after the procedure.

Manufacturer Narrative

Manufacturing site: toyoflex cebu corporation, cebu, philippines, registration number: (b)(4).The reported regalia xs 1.0 guide wire was returned for evaluation.The returned regalia xs 1.0 guide wire was found curved for approximately 15mm from the tip.The polymer jacket was peeled off for approximately 7mm from the tip, exposing the underlying outer coil.Proximal to the torn end of the polymer jacket, multiple scratch marks and stretch were observed on the polymer jacket.The ball tip was found attached on the very distal end of the regalia xs 1.0 guide wire, suggesting that the outer coil was not fractured.The returned corsair armet microcatheter was found with no damage such as kink which could be related to the reported case.When a 0.014inch guide wire was inserted into the corsair armet, the guide wire could be advanced through the catheter without resistance and no foreign objects were found coming out from the catheter.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 the metal tip of the concomitant corsair armet microcatheter had most likely contributed to peeling of the polymer jacket.It was likely that the guide wire was deformed due to anatomical conditions so that the wire surface would contact and be forcibly scraped by the edge of the catheter tip during pushing and pulling manipulation of either the guide wire or the microcatheter.It was concluded that this event was not attributed to product quality.It was unable to completely rule out a possibility that some polymer jacket fragment(s) might be left in the patient anatomy.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.~ do not use the guide wire in combination with catheters (atherectomy catheter, metallic dilator etc.) which metallic part may contact surface of this guide wire.[this guide wire may be damaged or separated.] ~ 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.[malfunction and adverse effects] ~ abrasion of the guide wire coating.

• Brand Name: REGALIA XS 1.0
• Type of Device: PERIPHERAL 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: lei sun ; 3-100 akatsuki-cho; seto, aichi 489-0-071 ; JA 489-0071
• MDR Report Key: 18307907
• MDR Text Key: 330225980
• Report Number: 3003775027-2023-00126
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 04547327131100
• UDI-Public: (01)04547327131100(17)260531(10)230619A11F
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K163426
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PAGP140300R
• Device Lot Number: 230619A11F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2023
• 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 Outcome(s): Other