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

Model Number CRV135-19P

Device Problems Break (1069); Entrapment of Device (1212); Failure to Advance (2524); Material Twisted/Bent (2981)

Patient Problems Calcium Deposits/Calcification (1758); Vascular Dissection (3160)

Event Date 07/25/2020

Event Type  malfunction  

Event Description

The patient's right radial artery was cannulated using modified seldinger technique and a 6-french slender sheath was advanced without difficulty.The doctor advanced a jacky catheter to the ascending aorta without difficulty.The jacky catheter was manipulated to selectively engage the right coronary artery and angiogram was obtained in multiple views.Following this, the same jacky catheter was manipulated to selectively engage the saphenous vein graft to the lad and angiogram was obtained in multiple views.Following this, the same jacky catheter was attempted to engage the left coronary artery but was unsuccessful.Then, the doctor switched the jacky catheter to a jl3.5 diagnostic catheter and was able to selectively engage the left main coronary artery and angiogram was obtained in multiple views.Following this, attempts were made to engage the saphenous vein graft to the circumflex but were unsuccessful with the initial attempts.Multiple catheters were tried including a jl3.5, jl4, al1, rcb and lcb catheters.Eventually, we were able to get jl3.5 to sub selectively engage the graft and angiogram was obtained in multiple views.Following this, the jl3.5 diagnostic catheter was switched to a pigtail catheter and was manipulated to cross the aortic valve and into the left ventricular cavity.Filling pressures were measured.On pullback, there were no significant gradients.At this point, angiograms were reviewed, and decision was made to proceed with pci to the rca and a staged revascularization to the left main supplying the diagonal territory.The patient was anticoagulated with heparin with a target act of more than 250 seconds.The doctor chose the al 0.75 guide and manipulated it to selectively engage the right coronary artery.Then, the doctor chose a runthrough wire over a finecross microcatheter.The doctor was able to cross the proximal lesion with a runthrough but could not cross the lesion with a finecross.Decision was made to switch the microcatheter.The doctor switched the microcatheter using a trap balloon to caravel.The doctor advanced the caravel to cross the proximal lesion to the mid lesion but could not be advanced beyond that mid lesion.The runthrough wire was removed and the doctor primarily wire the lesion with the rotaflex wire in anticipation of atherectomy given the severely calcified disease.Once we confirmed the position in the true lumen distally, we decided to remove the microcatheter and proceed with atherectomy.On removal, we noticed that a tip of the microcatheter got entrapped at the tip of the guide.At this point, the wire was left in place and requested additional help from another health care provider.We then advanced a new whisper wire parallel to the rotawire and put a wire.We used a 3.0 compliant balloon, which was inflated adjacent to the entrapped tip and was able to pull the whole unit without difficulty.We then switched the guide and started again.The guide was manipulated to selectively engage the right coronary artery.Angiogram at this point of time showed occluded distal vessel.It was unclear whether this is secondary to dissection causing acute vessel closure, but we were able to wire the lesion with a whisper wire, but again the patient will need atherectomy for stent optimization.Multiple microcatheters were tried using corsair and turnpike but could not cross the proximal lesion.We then reattempted caravel, which successfully crossed the proximal lesion and was able to cross the mid lesion as well at this time.Once we confirmed the location of the wire in the true lumen, we advanced a rotawire and we attempted to withdraw the caravel microcatheter and we had similar situation with the tip getting entrapped at the tip of the guide.At this time, decision was made to proceed with rotational atherectomy adjacent to the tip.We advanced a 1.25 burr and the primary doctor was able to cross the proximal lesion, however, could not cross the mid lesion despite multiple attempts.We decided to remove the rotablation catheter at this point and dilated the lesion using a 2.5 compliant balloon with reasonable angiographic result.This was made in an attempt to get the rotablation device further down, so that the mid lesion can be addressed.However, on pullback of the balloon catheter, the rotawire had kinked.We tried to exchange the wire with the help of a microcatheter and at this time, we used a turnpike microcatheter.Though we were able to get the catheter down across the proximal lesion, the wire got stuck inside the catheter and the microcatheter got stuck at the lesion in the mid segment.After with minimal force, we were able to remove the whole system out.The patient remained asymptomatic and without any ekg changes.We then advanced a jr4 diagnostic catheter for an angiogram, which showed dissection in the proximal segment and vessel closure in the mid segment, retained foreign body was in the mid segment the defective caravel microcatheter given to the mfr and returned to the manufacturer on july 28th of 2020.

• Brand Name: CARAVEL SUPPORT CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; 3002 dow ave suite 212; tustin CA 92780
• MDR Report Key: 10413120
• MDR Text Key: 203124578
• Report Number: 10413120
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CRV135-19P
• Device Catalogue Number: (01) 24547327108779(17)221231(
• Device Lot Number: 20108K07A
• 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: 08/06/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 26645 DA
• Patient Weight: 98