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

Device Problem Insufficient Information (3190)

Patient Problem Obstruction/Occlusion (2422)

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 occlusion, it was unable to determine how sheathless pv/eaucath had caused or contributed to the event.It was presumed that thrombus was likely formed during a procedure to induce occlusion because of the nature of intervention.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] - occlusion.

Event Description

It was reported through literature that asahi sheathless pv (distributed as sheathless eaucath) guide catheter might have caused or contributed to a minor occlusion.Publication: journal of endovascular therapy 2022, vol.29(2) 215-225 title: triaccess study: randomized comparison between radial, femoral, and pedal access for percutaneous femoro-popliteal artery angioplasty excerpt: [background] the aim of this randomized study was to compare the success and complication rates of different access sites for the treatment of superficial artery stenosis.[methods] the clinical and angiographic outcomes of 180 consecutive patients with symptomatic sfa stenosis were evaluated in a prospective randomized multicenter study between 2018 and 2019.Patients were randomized to the ra (n=60) or fa (n=60) and pa (n=60) groups.Tr sfa intervention: after local anesthesia, the radial artery was punctured with a dedicated tr needle and sheath (terumo co., japan, 5f).Advancement of the guidewire (gw) in the descending aorta was performed using a pigtail catheter and j-tip gw in a left lateral 40-degree view.In the case of a complex aortic arch, the loop technique with a pigtail catheter or simmons catheter was used.The aorta-femoral anatomy was identified in an anteroposterior view with aortography using a 5f 125 cm long pigtail catheter.The diagnostic catheter and introducer sheath were exchanged for a dedicated tr sheathless guide catheter (sg) system (asahi co., japan, 6.5f 90 cm or 6f 120 cm) over a 260-cm long 0.035 gw (starter or jindo, amplatz).After the procedure, all patients underwent a physical examination.All patients were scheduled for a detailed clinical follow-up examination at 3 and 6 months after the procedure.Furthermore, patients with cli and non-healing wounds were returned for the treatment of outflow disease.[results] the cumulative incidence of maces at 6 months in the ra, fa, and pa groups was 5%, 6.7%, and 1.7%, respectively (p=0.10).The cumulative incidence of males at 6 months in the ra, fa, and pa groups was 20%, 16.7%, and 10%, respectively (p=0.54).Cumulative rates of survival at 6 months were 96.7%, 95.0%, and 98.3% in the radial, femoral, and pedal groups, respectively (p=0.87).At 6 months, limb salvage was achieved in 96.7%, 96.7%, and 100.0% of patients in the ra, fa, and pa groups, respectively (p=0.55).Major amputation was necessary in 3.3%, 3.3%, and 0.0% of the patients in the ra, fa, and pa groups, respectively (p=0.55).The cumulative rates of access site complications in the ra, fa, and pa groups were 3.3% (0% major and 3.3% minor), 16.7% (3.3% major and 13.3% minor), and 3.3% (3.3% major and 0% minor), respectively (p=0.01).The sheath size, and the sheath change has not influenced significantly the rate of vascular access site complications.Anterograde and cross over access has been applied in 54 (90%) and in 6 (10%) patients.The rate of vascular complications in the anterograde and cross over cases was 10% [2 major (20%) and 8 minor (80%)] and 0% (p=0.57).Table 4.Perioperative complications: access site complication (minor occlusion in 1 patient).

• 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: 16011064
• MDR Text Key: 305779626
• Report Number: 3003775027-2022-00164
• 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

• 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
• Initial Date Manufacturer Received: 12/09/2022
• Initial Date FDA Received: 12/19/2022
• 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