MAUDE Adverse Event Report: ASAHI INTECC PROWATER FLEX; GUIDE WIRE

Model Number N/A

Device Problem Difficult or Delayed Positioning (1157)

Patient Problems Chest Pain (1776); Low Blood Pressure/ Hypotension (1914); Thrombus (2101); Vascular Dissection (3160)

Event Type  Injury  

Event Description

Aortic dissection caused by percutaneous coronary intervention: 2 new case reports and[?]detailed analysis of 86 previous cases".The diagnostic catheter was immediately removed, and a 6f jr4 guide catheter was used without difficulty to engage the rca.A 180-cm asahi prowater flex guidewire (abbott vascular, part of abbott laboratories; abbott park, ill) was inserted into the rca but could not cross the culprit lesion.This wire was exchanged for a 190-cm hi-torque whisper guidewire (abbott vascular), and the lesion was successfully crossed with support from a 1.5 × 15-mm maverick over-the-wire balloon catheter (boston scientific corporation; natick, mass).Two brief inflations were done at pressures of 12 atm within the stent for 10 s each.The wire was upgraded to a 300-cm asahi prowater flex wire while the maverick balloon was still inside the artery.The patient reported chest pain, and his systolic blood pressure (sbp) fell to 78 mmhg.The balloon was removed.An angiogram showed dissection of the proximal rca, extending retrograde into the right aortic cusp and ascending aorta (fig.1).In addition, slow flow and evidence of thrombus were noted in the rca.

• Brand Name: PROWATER FLEX
• Type of Device: GUIDE WIRE
• Manufacturer (Section D): ASAHI INTECC; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 11311454
• MDR Text Key: 231308314
• Report Number: 3004718255-2021-00200
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/11/2021,02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UKN
• Device Lot Number: UKN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/11/2021
• Distributor Facility Aware Date: 02/09/2021
• Event Location: Hospital
• Date Report to Manufacturer: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 52 YR