MAUDE Adverse Event Report: AV-ASAHI ASAHI FIELDER XT PTCA GUIDE WIRE

Catalog Number	AGP140302
Health Effect - Clinical Code	Perforation (2001)
Date of Event	09/23/2016
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.The analysis was performed by asahi intecc.Co.Ltd: the device was not returned for evaluation.A review of the lot history record and complaint history could not be conducted because the lot number was not provided.The instructions for use (ifu) lists cardiac perforation as a possible complication and adverse event.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The device is manufactured by asahi intecc.Co.Ltd.(b)(4).(b)(4) distributes the device and is responsible for mdr reporting.
Event or Problem Description
It was reported that the procedure was to treat a lesion located in a chronic totally occluded (cto) right coronary artery.A fielder xt 300 guide wire was successful in crossing the cto; however, sometime during use of the guide wire a perforation was observed.The guide wire was retracted, balloon angioplasty was performed and the procedure continued on.After placement of non-abbott stents a 3.5 x 16 mm graftmaster covered stent was used successfully for treatment of the perforation.The final outcome was good.No additional information was provided.

• Brand Name: ASAHI FIELDER XT 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: 6034123
• Report Number: 3003775027-2016-00192
• Device Sequence Number: 13662685
• Product Code: DQX
• UDI-Device Identifier: 04547327072861
• UDI-Public: (01)04547327072861
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K072431
• 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): 10/17/2016

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: AGP140302
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2016
• Initial Report FDA Received Date: 10/17/2016
• 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: GUIDE CATHETER: CARAVEL MICROCATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Weight: 75