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

Catalog Number	14940-01
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/14/2017
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.Estimated date of occurrence.(b)(4).The analysis was performed by asahi intecc.Co.Ltd: device investigation of the grand slam guide wire could not be conducted as it was not returned.Based on the provided information, it was presumed that rotational and/or pulling force exceeding the products design limit might be inadvertently given to the grand slam guide wire while its distal tip was trapped by the heavy calcium of the lesion.Although device investigation of the subject guide wire could not be conducted, since all the shipped products were inspected in the production process for meeting the product specifications and release criteria, there was no indication of a product deficiency.
Event or Problem Description
It was reported that the procedure was to treat a heavily tortuous and heavily calcified lesion in the lower extremity.An atherectomy device was advanced over an asahi grandslam guide wire; however, the guide wire separated.A snare was used to successfully remove the separated portion of the guide wire.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

• 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: 6904143
• Report Number: 3003775027-2017-00177
• Device Sequence Number: 852442
• Product Code: DQX
• UDI-Device Identifier: 04547327055857
• UDI-Public: 04547327055857
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 09/29/2017

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: 11/30/2019
• Device Catalogue Number: 14940-01
• Device Lot Number: 161216A091
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2017
• Initial Report FDA Received Date: 09/29/2017
• 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: Required Intervention