MAUDE Adverse Event Report: AV-ASAHI ASAHI GRANDSLAM PTCA GUIDE WIRE

Model Number	AG141302
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/29/2018
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.Concomitant medical product: pinnacle destination introducer sheath; pioneer reentry device.Failure to follow steps.The analysis was performed by asahi intecc.Co.Ltd: the device was not returned for analysis.Lot history review revealed no anomaly relating to the reported event and no other similar product experience report was received.Instructions for use states: do not use this guide wire in combination with catheters (atherectomy catheter, metallic dilator etc.) which metallic parts may contact surface of this guide wire.Otherwise, this guide wire may be damaged or break apart.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.The device is manufactured by (b)(4).Abbott vascular distributes the device and is responsible for mdr reporting.The emboshield referenced is filed under a separate medwatch report number.
Event or Problem Description
It was reported that on (b)(6) 2018, the patient underwent a peripheral procedure to treat a target lesion in the heavily calcified and tortuous iliac artery.The emboshield nav6 embolic protection device was placed for distal protection.The grand slam guide wire was placed subintimally.During use of a non-abbott reentry device, the reentry device needle pierced the guide wire and sheared off a portion of the guide wire.The separated guide wire portion remains in the patient anatomy.No attempt was made to remove the separated guide wire segment.The emboshield nav6 embolic protection device filter was pulled into the retrieval catheter without difficulty; however, during removal, the retrieval catheter kinked and was difficult to remove from the non-abbott introducer sheath.The introducer sheath and retrieval catheter were removed as a single unit.There was no adverse patient effect with regards to the emboshield nav6.No additional information was provided.
Additional Manufacturer Narrative
Asahi intecc has determined that the date recorded in block b4 "date of this report" was erroneously reported as the date the report was submitted rather than the date the initial reporter provided the information about the event to the company.Corrective action has been taken to clarify which date should be provided in the report.This supplemental report is intended only to correct the date provided in block b4 to reflect the date the initial reporter provided the information about the event to the company.

• Brand Name: ASAHI GRANDSLAM 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: 7420088
• Report Number: 3003775027-2018-00071
• Device Sequence Number: 554801
• Product Code: DQX
• UDI-Device Identifier: 04547327055857
• UDI-Public: 04547327055857
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K031277
• 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): 03/29/2018

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: 10/31/2018
• Device Model Number: AG141302
• Device Catalogue Number: 14940-01
• Device Lot Number: 151117A051
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/29/2018
• Supplement Date Received by Manufacturer: 03/29/2018
• Initial Report FDA Received Date: 04/10/2018
• Supplement Report FDA Received Date: 01/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 FOR CONCOMITANT MEDICAL DEVICES
• Outcome Attributed to Adverse Event: Other
• Patient Age: 76 YR