MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. ASAHI GLADIUS MONGO 14; PTCA GUIDE WIRE

Catalog Number	AP14R023S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluation could not be performed because the device was discarded by the facility.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 provided information and referring to known similar events, it was presumed that tensile stress generated with wire removal had most likely contributed to the reported coil elongation as the guide wire was caught and restricted its movement by the existing stent or the severely calcified cto.Along with coil elongation, separation of the core possibly occurred.Possible damage on the core could be caused by bending stress and torsion generated with wire manipulation performed in attempts to cross the lesion.It was concluded that this event was not attributed to product quality.Instructions for use (ifu) states: [warnings] if any resistance is felt due to spasm or the guidewire being bent or trapped while operating the guidewire in the blood vessel or removing it, do not move or torque the guidewire.Stop the procedure.Determine the cause of resistance under fluoroscopy and take appropriate remedial action.If the guidewire is moved excessively, it may break or become damaged, which may cause blood vessel injury or result in fragments being left inside the vessel; and, [malfunction and adverse effects] separation of the guide wire.
Event or Problem Description
It was reported that an asahi gladius mongo 14 guide wire was used in a pci to treat a significantly tortuous, significantly calcified cto in the mid lad.The physician was initiating a cto pci cross of the lesion.As the wire was advanced through the complex anatomy, the physician found that the wire became stuck.He felt that it was either behind a stent strut or was wedged badly into the 100% calcific lesion.As he pulled backward, the wire came apart on the spring coil and elongated.However, he was able to retrieve the entire wire and start over with a new one.The wire was retrieved successfully back into the concomitant corsair pro microcatheter and removed from the body.The wire was immediately thrown away and a new one re-introduced.The physician was able to get through the lesion and eventually treat the cto with great patient outcome.There were no adverse patient effects associated with this wire malfunction.

• Brand Name: ASAHI GLADIUS MONGO 14
• Common Device Name: PTCA GUIDE WIRE
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 9730211
• Report Number: 3003775027-2020-00038
• Device Sequence Number: 10854381
• Product Code: DQX
• UDI-Device Identifier: 04547327123686
• UDI-Public: (01)04547327123686(17)220731(10)190822A011
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180784
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: AP14R023S
• Device Lot Number: 190822A011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2020
• Initial Report FDA Received Date: 02/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 116