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

Device Problem Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Obstruction/Occlusion (2422); Vascular Dissection (3160)

Event Type  Injury  

Manufacturer Narrative

Manufacturing site was unable to be identified because lot information was unavailable.Multiple asahi devices were used in this study; however, how sheathless guide catheter had caused or contributed to rao, rca ostial dissection, or access-site complications occurred in this study was unable to be determined based on the limited written information.Referring to known similar events, it was presumed that patient anatomy and procedural contents were most likely associated with perforation cases in the study.It was also inferred that wrong size selection of a sheathless guide catheter could be associated with occurrence of rao; it was written in the aras "a 4-fr conventional sheath was subsequently exchanged for a 7.5-fr sheathless guiding catheter" while the how to insert section of the instructions for use (ifu) states "the combinations of guide catheter and sheath introducer are as follows: catheter 6.5fr = sheath introducer 4fr; catheter 7.5fr = sheath introducer 5fr." lot history records review could not be conducted because of unavailability of lot information.Because 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.Ifu states: [warnings]: operate this guide catheter carefully, and if any resistance is felt, stop the manipulation and identify the cause of the resistance under x-ray fluoroscopy.Note that when using in combination with other devices, especially when inserting, for example, 5fr device into 6.5fr guide catheter, and the clearance between the lumen of guide catheter and the combined device is small, the combined device may be stuck in the catheter.[otherwise, trauma and/or damage of the guide catheter may occur.] do not insert the guide wire by force or advance it rapidly when the guide catheter is bent or twisted.[the guide wire may cause perforation or damage of the guide catheter, or result in trauma.] manipulate the guide catheter in the vessel carefully by observing it under a high-definition x-ray fluoroscopy monitor screen.If any resistance is felt during operation or if torque manipulation is not transmitted to the catheter distal end, discontinue the operation and identify the cause.Catheter may be kinked and/or twisted.[continued operation against resistance or removal of catheter by force may damage the blood vessel, or cause a separation of this guide catheter.] [precautions]: when inserting this product into the blood vessel, pay attention not to damage the wall of vessel by the dilator and the tip of this guide catheter (the size or stiffness).According to preoperative coronary angiography, if there is a possibility the tip of guide catheter contacting plaque when engaging the guide catheter in the coronary ostium, the risk of coronary dissection is high.Avoid using guide catheter in this case.[malfunction and adverse effects]: bleeding complications, vascular complications, complication of puncture site, dissection, hemorrhage.

Event Description

It was reported through a research article titled "slender sheath/guiding catheter combination vs.Sheathless guiding catheter for acute coronary syndrome: a propensity-matched analysis of the two devices" (journal of interventional cardiology, volume 2020, article id 821683) that identified an asahi product may be related to vessel dissection in the right coronary artery, or access-site complications.Excerpt is as follows: a glidesheath slender (terumo, tokyo, japan) and a sheathless eaucath guiding catheter (asahi intecc, nagoya, japan) are two major slender devices utilized in percutaneous coronary intervention (pci).This study aimed to investigate the differences in access-site complications between these devices in pci for acute coronary syndrome (acs).A total of 1108 consecutive patients who underwent transradial pci for acs were enrolled.Transradial pci was performed using either a 7-fr glidesheath slender/7-fr guiding catheter combination (glidesheath group) or a 7.5-fr sheathless guiding catheter (sheathless group); 1:1 propensity score matching was performed, and 728 patients (364 in each group) were included in the propensity-matched population.The choice of guiding system (7.5-fr sheathless guiding catheter or 7-fr glidesheath slender sheath/7-fr guiding catheter combination) was at the operator's discretion.In cases where a 16 cm-long 7-fr glidesheath slender sheath was selected, after coronary angiography using a 4-fr diagnostic catheter with a 7-fr glidesheath slender sheath, a 7-fr hyperion guiding catheter equipped with an inner dilator (5.5-fr sta angiography catheter; medikit, tokyo, japan) was inserted into the radial artery via the glidesheath slender.In cases where the 7.5-fr sheathless guiding catheter was selected, a sheath-cum-sheathless technique was used.After coronary angiography using a 4-fr diagnostic catheter with a 4-fr conventional sheath, a 4-fr conventional sheath was subsequently exchanged for a 7.5-fr sheathless guiding catheter connected to a supplied central dilator over a j-tipped 0.035-inch guidewire and inserted into the radial artery.All pci procedures were performed after intra-arterial heparin administration (10,000 u).The activated clotting time (act) was noted 3 min after the first administration of heparin and every 1 h thereafter.Heparin was administered additionally to maintain an act of >-300 s.End-procedural act was immediately measured before removing the guiding catheter at the end of the procedure.In the matched patients, univariate analysis revealed that the glidesheath group had less radial artery occlusion (rao) at 30 days (glidesheath: 1.4% vs.Sheathless: 4.1%, odds ratio (or) =0.33, 95% confidence interval (ci) = 0.12-0.91, p = 0.039), whereas no significant between-group differences were observed in severe radial spasm (glidesheath: 1.4% vs.Sheathless: 1.9%, or= 0.71,95% ci =0.23-2.22, p = 0.58) or access-site major bleeding (glidesheath: 1.4% vs.Sheathless: 1.6%, or= 0.83, 95% ci = 0.26-2.71,p = 1.00).In our opinion, the different nature of radial artery injury at the puncture site might have caused the significantly different incidences of rao between the two groups: a 7-fr glidesheath slender with a dilator directly tracking on a guidewire after radial puncture versus graded injury by a 4-fr sheath, followed by a 7.5-fr sheathless guiding catheter on the dilator.Studies have shown that a larger-bore device causes more rao, and the outer diameter of the 7-fr glidesheath slender is larger than that of the 7.5-fr sheathless guiding catheter by 0.30 mm.By comparison, the incidences of rao of conventional 6-fr sheaths are reportedly 3.5%-15.2% at >-2 days after pci.Therefore, our data suggest that using both the 7-fr glidesheath slender sheath and 7.5-fr sheathless guiding catheter have equal or lower risk of rao compared to conventional 6-fr sheaths.Second, the overall incidences of access-site complications were low in the glidesheath and sheathless groups with no significant differences between them except for rao; the incidence of severe radial spasm during pci was low, but not significantly different between both them in the present study.Access-site major bleeding events were not significantly different between the two groups.This is contradictory to a previous meta-analysis that demonstrated that a 5-fr system in transradial pci significantly reduces bleeding frequency compared to a 6-fr system; the difference in outer sheath size between the 5-fr and 6-fr sheaths was approximately 0.4 mm.This suggested that the difference in outer sheath size between 7-fr glidesheath slender and 7.5-fr sheathless guiding catheter (0.3 mm) was too small to cause a significant difference in the incidence of access-site major bleeding events between the two groups.Finally, the rates of catheter-induced coronary dissection were not significantly different between the two groups.In our study (n = 1108), coronary ostial dissection occurred in 13 patients.Of note, 9 patients experienced right coronary artery (rca) ostial dissection (2.8% (6/217) for the sheathless group and 2.2% (3/139) for the glidesheath group, p = 0.75, respectively).In our opinion, rca dissections may have been directly related to the lesion characteristics and not the choice of the sheathless guiding catheter because in our study, most dissections occurred in rcas with moderate ostial stenosis.Therefore, in patients with moderate ostial stenosis of the rca, caution should be exercised during positioning and coaxial alignment of the guiding catheters with the artery, irrespective of the catheter type.

• 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: 11211640
• MDR Text Key: 232827394
• Report Number: 3003775027-2021-00013
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K132556
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2021
• 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: 01/05/2021
• 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