MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. CORSAIR; PERCUTANEOUS CATHETER

Device Problem Insufficient Information (3190)

Patient Problem Perforation of Vessels (2135)

Event Type  Injury  

Manufacturer Narrative

Manufacturing site: manufacturing site could not be determined because the product lot number information was not available.Device investigation could not be performed because the device was not returned.Investigation of production records could not be performed because lot information was unavailable.Although the device investigation and lot history review could not be conducted, all the shipped products were inspected in the production process for meeting the product specifications and release criteria; therefore, it was concluded there was no indication of product deficiency.It was presumed that location of the tip of the unspecified device was not confirmed when attempts were made to cross the lesion; direction of the device tip might have been deviated due to calcification.Whether the corsair had contributed to this event was unable to be confirmed.It was inferred that anatomical condition and operator's manipulation technique most likely contributed to the vessel perforation.Instructions for use (ifu) states: [contraindications] do not use this microcatheter in advanced calcified lesion; [warnings] this microcatheter must always be operated under high-resolution fluoroscopic guidance.Particular attention should be paid when inserting or withdrawing this microcatheter into or through stenotic areas, and narrower vessels than the microcatheter.(abrasion may result in damage of this microcatheter.This may cause vascular injury and perforation.); [warnings] repeated insertion and withdrawal of this microcatheter may lead to deterioration of the hydrophilic coating.(continuous use of this microcatheter with deteriorated hydrophilic coating may cause vascular damage.This may also increase the risk of trapped tip, and cause a damage of the tip.); and, [malfunction and adverse effects] vessel dissection or perforation.

Event Description

According to a case report titled "rotational atherectomy with the new rotapro system over rg3 guidewire in subadventitial retrograde highly calcified cto pci" in catheterization and cardiovascular interventions 2020;95:242-244, vessel perforation occurred during the procedure where multiple asahi and non-asahi devices were used.Which device had contributed to the perforation was not mentioned in this case report.It was written as follows: the case report refers to a (b)(6)-year-old man with previous history of cad and left anterior descending (lad) pci affected by ccs 3 stable angina.Echocardiography showed severe left ventricular dysfunction (ef 25%) with anterior-apical akinesia and inferior hypokinesis with normal inferior wall thickness and mild mitral regurgitation.At coronary angiography severely calcific right coronary artery (rca) cto, with rentrop 3 homo and etero-collateralization (j-cto score 4), and ostial intrastent lad cto with poor collateralization were observed (movie s1-s3, figure 1a).Since high surgical risk was foreseen due to severe comorbidities, the patient underwent to rca cto pci.An initial anterograde wire-escalation and dissection re-entry with "knuckle technique" (see table 1) were attempted with guidezilla 7 fr (boston scientific corp.), corsair 135 cm (asahi-intecc), center cross (roxwood medical, figure 1b) without success despite hornet 14 (boston scientific corp) and astato 20 (asahi-intecc) and filder xt a (asahiintecc) guidewires.Thus, a retrograde approach resulted successful in crossing an epicardial collateral with corsaire 150 cm and sion black (asahi-intecc) (movie s4).A retrograde wire escalation only partially penetrated within the cto body with gladius (asahi-intecc) (movie s5) and therefore an antegrade "scratch'n'go" with "base" technique followed by and an ivus guided reverse cart was performed to establish the connection successfully (figure 1c,d).Subsequently a guidezilla assisted externalization was performed and switched to rg3 (asahi-intecc) guidewire.Due to acute marginal perforation a 3.0/80 coil was placed (movie s6).Several predilatations were attempted without acceptable expansion and both antegrade or retrograde deliverability (figure 1e).A switch to rotawire (boston scientific corp.) was tried with "tip-in" technique without success (movie s7).Lastly rotational atherectomy (ra) with 1.25 mm burr with rotapro (boston scientific corp.) was performed (movie s8) over rg3 guidewire; predilatation and subsequent implantation of four drug eluting stent synergy (boston scientific corp) were achieved with a good final result (movie s9 and s10, figure 1f).The patient was discharged after 4 days without any complication.No events were observed in the frame of the 6-months follow-up where the transthoracic echocardiography showed left ventricle improvement with an ejection fraction 35%.

• Brand Name: CORSAIR
• Type of Device: PERCUTANEOUS 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: 10198057
• MDR Text Key: 198011494
• Report Number: 3003775027-2020-00094
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K171933
• 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: 06/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2020
• 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: 06/15/2020
• 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): Required Intervention
• Patient Age: 52 YR