MAUDE Adverse Event Report: AV-ASAHI ASAHI SION BLUE PTCA GUIDE WIRE

Catalog Number	AHW14R004S
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	08/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The analysis was performed by asahi intecc.Co.Ltd: the device was not returned.Based on the provided information, it was presumed that pulling force exceeding the products design limit might be inadvertently given to the guide wire while its tip was trapped by the calcium and/or stent.All the shipped products were inspected in the production process for meeting the product specifications and release criteria, and there was no indication of product deficiency.
Event or Problem Description
It was reported that the procedure was to treat a lesion located in the right coronary artery that was heavily calcified from the beginning to end of bifurcation.The vessel was wired in the right coronary artery to the posterior descending artery (pda).After stent deployment and when the asahi sion blue 180 cm guide wire was being removed, it was noticed that the tip of the guide wire had broken off in the anatomy.The tip was left in the anatomy when it was confirmed that the vessel still had good flow.The tip remains embedded in the pda.There was no resistance noted during advancement or withdrawal.There was no reported adverse patient effect.There was no reported clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Internal file number - (b)(4).Correction: other, serious removed and required intervention added the analysis was performed by asahi intecc.Co.Ltd: investigation of the device could not be conducted as it was not returned.Based on the provided information, it was presumed that pulling force exceeding the product design limit might be inadvertently given to the guide wire while its tip was trapped by the calcium.All the shipped products were inspected in the production process for meeting the product specifications and release criteria, and there was no indication of product deficiency.As it was confirmed that the device had no quality issues, it was inferred that the reported vessel perforation was attributed to the anatomical condition and wire manipulation technique; however, details could not be ascertained.[malfunction and adverse effects] separation or breakage of the guide wire, damage to a vessel, including possible vessel perforation.
Event or Problem Description
Subsequent to the previously filed medwatch report, asahi received a user facility medwatch report from fda.After follow-up with the physician, the medwatch report information is correct.The coronary was perforated and blood flow was occluded, however the patient was stabilized after ballooned with a long inflation and stenting with a non-abbott stent.The patient date of birth is (b)(6) 1949 the patient is (b)(6) years old.

• Brand Name: ASAHI SION BLUE PTCA GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): AV-ASAHI; asahi intecc co. ltd med div; 3-100 akatsuki-cho; seto 489-0 071; JA 489-0071
• MDR Report Key: 6849954
• Report Number: 3003775027-2017-00159
• Device Sequence Number: 16174191
• Product Code: DQX
• UDI-Device Identifier: 04547327086226
• UDI-Public: 04547327086226
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K100578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2017

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: 03/31/2020
• Device Catalogue Number: AHW14R004S
• Device Lot Number: 170417A041
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/15/2017
• Supplement Date Received by Manufacturer: 10/10/2017
• Initial Report FDA Received Date: 09/07/2017
• Supplement Report FDA Received Date: 10/12/2017
• 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: Other; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 82