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

Catalog Number CRV135-19P

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Device Embedded In Tissue or Plaque (3165)

Event Date 07/25/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturing site: (b)(6), registration number: (b)(4).Device investigation could not be performed because the device was not returned.Lot history review revealed no anomaly relating to the reported event.No other similar product experience report was received from this lot.Reviewing on the applicable manufacturing records found no indication of product deficiency.As indicated in the provided information, it was presumed that the caravel tip was likely damage during crossing the severely calcified lesions, and the damaged caravel tip was torn off at the time it was trapped by the tip of the concomitant guide catheter during removal.It was concluded that this event was not attributed to product quality.Instructions for use (ifu) states: contraindications do not use this microcatheter in advanced calcified lesion; warnings if any resistance or something abnormal is felt when operating this microcatheter, do not continue the manipulation while the causes are unclear.If it is suspected that this microcatheter is not operating correctly, avoid excessive manipulations, and carefully remove the entire catheter system while paying full attention to avoid complications.(continuing the manipulation while the cause of the problem is not identified may cause damage to this microcatheter, and damage the blood vessel.); and, malfunction and adverse effects:separation.

Event Description

It was reported that the target rca was a moderate sized dominant vessel with multiple lesions: 50% stenosed ostial lesion; proximal 90% and 80% sequential stenoses with severe calcification; mid segment 95% stenosis with severe calcification; and distal segment 70% stenosis just at the bifurcation to the moderate sized pda and a small rpl branch.During an rca interventional procedure, an al 0.75 guide catheter was manipulated it to selectively engage the rca.A run through guide wire was used to cross the proximal lesion.A fine cross microcatheter was unable to cross and "trapped" out to exchange for an asahi caravel microcatheter.The caravel passed the proximal lesion, but could not advance beyond the mid lesion.A rotowire was swapped for the run through.The caravel was then backed out and became "entrapped" at the tip of the guide catheter.A parallel wire (whisper) was used and dilation was performed with a 3.0 compliant balloon to assist with caravel removal.It was able to pull the whole unit without difficulty.The guide wire was also removed and the guide catheter was changed for improved support.The rca was re-wired with a whisper guide wire.A turnpike and an asahi corsair pro microcatheters were used to cross the proximal lesion with no success.A second caravel was then opened and used to advance into the rca which passed the proximal and mid lesions.True lumen confirmation of wire was made and the guide wire was exchanged for a rotowire in anticipation of rotational atherectomy.The second caravel was then backed out only to be entrapped at the tip of the guide catheter like the previous caravel microcatheter.Rotational atherectomy with a 1.25 burr was performed adjacent to the caravel tip through the proximal section of the vessel but with no success in the mid lesion.Dilation with a 2.5 compliant balloon was performed on the mid lesion with improved blood flow.The procedure halted due to time of fluoroscopy and contrast limitations.The patient was fine without adverse effects after the procedure and would returned in 4-6 weeks for follow-up therapy on the rca.The operators attributed the loss of the caravel tip was due to the extreme calcium and possible distortion of the tip of the guide catheter.

Manufacturer Narrative

The caravel microcatheter was returned for evaluation.Tip separation was confirmed.Scratches likely made by contacting calcium were observed on the shaft.Shaft strands were found disarranged due to accumulated torsion.Microscopic observation of the tip found that the torn end of the tip was facing outward.Multiple circumferential cracks were observed proximal to the torn end.These findings indicated that tensile stress had contributed to the observed tip separation.Measurement of the remaining tip suggested that approximately 2mm of the tip was missing.Based on the provided information and investigation outcome, it was presumed that the caravel tip was likely damage during crossing the heavily calcified lesions.Due to severe calcification, movement of the tip was likely restricted when attempts were made to cross the lesion; therefore, tensile or torsional stress generated with manipulation could exceed the product design limit and damage the tip.And the damaged tip would detach from the body likely at the time it was trapped by the tip of the concomitant guide catheter during removal.It was concluded that this event was not attributed to product quality.Instructions for use (ifu) states: [contraindications] do not use this microcatheter in advanced calcified lesion; [warnings] do not rotate this microcatheter in any situation.(rotating this microcatheter may cause damage to the microcatheter, and may also damage the blood vessel.); [warnings] if any resistance or something abnormal is felt when operating this microcatheter, do not continue the manipulation while the causes are unclear.If it is suspected that this microcatheter is not operating correctly, avoid excessive manipulations, and carefully remove the entire catheter system while paying full attention to avoid complications.(continuing the manipulation while the cause of the problem is not identified may cause damage to this microcatheter, and damage the blood vessel.); and, [malfunction and adverse effects] separation.

• Brand Name: CARAVEL
• Type of Device: PERCUTANEOUS CATHETER
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 10406198
• MDR Text Key: 210183377
• Report Number: 3003775027-2020-00125
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 04547327108775
• UDI-Public: (01)04547327108775(17)221231(10)200108K0A
• Combination Product (y/n): N
• PMA/PMN Number: K152447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 07/31/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: CRV135-19P
• Device Lot Number: 200108K10A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Initial Date Manufacturer Received: 07/31/2020
• Initial Date FDA Received: 08/14/2020
• Supplement Dates Manufacturer Received: 08/18/2020
• Supplement Dates FDA Received: 09/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 73 YR
• Patient Weight: 90