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

Catalog Number	AG14M070
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	10/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device investigation could not be performed because the device was not returned.Lot history review revealed no anomaly relating to the reported event.No other similar product experience report was received for this lot.Based on the provided information and referring to know similar events, it was presumed that tensile stress generated with repeated attempts to remove the stuck guide wire in the lesion had most likely contributed to the reported wire separation.When the tensile stress exceeded the product's design limit, it caused the guide wire to fracture and eventually separated.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
Uf report #: (b)(4) was received from the us importer on october 24,, 2019.It was reported that the patient underwent a cardiac catheterization for an rca pci.Multiple attempts were made to open the blockage.During this process, a wire was unable to be removed for the rca.Multiple snares were deployed to remove the wire, however each attempt unsuccessful.Finally a radial jaw was use to pull the wire.Wire broke and was removed from the patient's radial artery.A fragment of the wire remains in the patient's rca.No patient harm noted.

• Brand Name: ASAHI MIRACLEBROS 12
• Common Device Name: PTCA GUIDE WIRE
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, 489-0 071; JA 489-0071
• MDR Report Key: 9307291
• Report Number: 3003775027-2019-00183
• Device Sequence Number: 13996340
• Product Code: DQX
• UDI-Device Identifier: 04547327058131
• UDI-Public: (01)04547327058131(17)210430(10)180512A021
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K052339
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/24/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: AG14M070
• Device Lot Number: 180512A021
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2019
• Initial Report FDA Received Date: 11/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 76 YR
• Patient Weight: 89