MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. SHEATHLESS EAUCATH; GUIDE CATHETER

Device Problem Insufficient Information (3190)

Patient Problems Hematoma (1884); Obstruction/Occlusion (2422); Embolism/Embolus (4438)

Event Type  Injury  

Manufacturer Narrative

Manufacturing site: manufacturing site could not be identified because the product lot number information was not available.Device evaluation could not be performed because the affected device was not returned.Lot history records review could not be conducted because lot information was unavailable.All the shipped products were inspected in the production process and satisfied the product specifications and release criteria; therefore, it was concluded that there was no anomaly in product quality.Due to limited written information in this article on what had caused the reported distal embolization, forearm hematomas, or radial artery occlusions, it was unable to determine how sheathless eaucath had caused or contributed to these complications.It was presumed that thrombus was likely formed during a procedure to induce occlusion because of the nature of intervention.Hematoma formation is known to be associated with anatomical conditions and the operator's technique and could occur in any procedure using an interventional device.It was concluded that these adverse events were not attributed to product quality.No capa will be taken.Instructions for use (ifu) states: [malfunction and adverse effects] - arterial embolism, thrombosis or occlusion - hematoma.

Event Description

It was reported through literature that an asahi sheathless pv (distributed as sheathless eaucath in the us) guide catheter might have caused or contributed to distal embolization, forearm hematoma, and radial artery occlusion.Publication: journal of endovascular therapy 2021, vol.28(2) 255-261 title: distal radial artery access for superficial femoral artery interventions [purpose].To compare the acute success and complication rates of distal radial (dr) vs proximal radial (pr) artery access for superficial femoral artery (sfa) interventions.[methods].Between 2016 and 2019, 195 consecutive patients with symptomatic sfa stenosis were treated via dr (n=38) or pr (n=157) access using a sheathless guide.The diagnostic catheter and introducer sheath were exchanged for a dedicated, 6-f, 120-cm-long peripheral transradial sheathless guiding system (sheathless pv; asahi intecc, aichi, japan) over a 260-cm-long, 0.035-inch guide wire (starter or jindo, amplatz) in pr cases.For dr cases, a 6-f, 100-cm coronary transradial sheathless guide was used (eaucath; asahi intecc).All patients were immediately mobilized after the procedure and underwent a physical examination.On the first postoperative day, the patency of the radial artery was evaluated if it was not palpable at the puncture site.[results] one patient in the pr group suffered a distal embolization that was successfully treated with manual thrombus aspiration; no major procedural complications were encountered in the dr group.The rates of access site complications in the dr and pr group were 2.6% and 7%, respectively (p=0.46).The only access site complication in the dr group was a minor hematoma, while 1 pr patient had a hematoma >2 cm in the forearm.Ten other patients in the pr group had minor access sequelae including 7 asymptomatic radial artery occlusions and 3 forearm hematomas.Six dr patients (15.7%) and 23 pr patients (14.6%) had maes at 6 months.Three patients (7.8%) in the dr group died vs 8 in the pr group (5.1%; p=0.38).

• Brand Name: SHEATHLESS EAUCATH
• Type of Device: GUIDE CATHETER
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• Manufacturer (Section G): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• Manufacturer Contact: yukako homma ; 3-100 akatsuki-cho; seto, aichi 489-0-071 ; JA 489-0071
• MDR Report Key: 16011056
• MDR Text Key: 305786029
• Report Number: 3003775027-2022-00163
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: HU
• PMA/PMN Number: K132556
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention