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

Catalog Number CRV135-19P

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/08/2018

Event Type  Injury  

Manufacturer Narrative

Manufacturing site: asahi intecc hanoi co., ltd.(b)(4).The microcatheter and its separated tip were returned for evaluation.The returned microcatheter had its broken tip fattened.Proximal to the broken end of the tip, circumferential cracks were on the tip surface.At the tip breakage end, the inner polymer jacket and tip polymer were found stretched and underlying braids were exposed.These findings suggested the tip was torn off due to tensile stress.The separated tip was approximately 3 mm long.The tip polymer was found stretched and circumferential cracks were seen on the tip surface as seen on the proximal side of tip breakage.There were also relatively deep scratches on the tip surface that seemed to be made by contact with calcium.The tip end was flattened.The above findings suggested that the tip broke due to tensile stress and torn at approximately 2 mm proximal to the tip end where crossed the border between the polymer-only segment and polymer-and-braids segment.Lot history review revealed no anomaly relating to the reported event.Another tip separation case was reported for this lot; however, the cause of the tip separation was excess torsion that caused the tip to be twisted and eventually wrenched off unlike this reported event.Based on the obtained information and investigation outcome, it was concluded that tip separation was attributed to tensile stress exceeding the product's design limit that was inadvertently applied on the microcatheter while the catheter tip was being trapped and crushed by the moderately tortuous and heavily calcified lesion.There was no indication of product deficiency.Although the separated tip was successfully retrieved, the tip was too severely damaged to completely excluded a possibility that some fragment(s) might be left in the anatomy.Instructions for use (ifu) states that: [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, [malfunctions] separation.

Event Description

It was reported that the tip of an asahi microcatheter became separated during a pci to treat a moderately tortuous and heavily calcified 90-99 % stenosis in the lcx #11-13.A guide wire was advanced with the microcatheter and crossed the lesion.Ivus was then planned to be performed, however, the ivus catheter could not cross.To use a rotablator, the microcatheter was again advanced for wire exchange.After the microcatheter was removed, a rota burr was delivered when the separated catheter tip was found on the wire under fluoroscopy.Another catheter was delivered in an attempt to cover the separated tip.A balloon was inflated inside the catheter lumen to hold the separated tip.The wire, catheter, and balloon were then removed all together.After successful retrieval of the separated tip, the pci was resumed with rotablation.The blood flow was successfully reestablished by stenting.The patient was reportedly without problem after the procedure.

Manufacturer Narrative

Asahi intecc has determined that the date recorded in block b4 "date of this report" was erroneously reported as the date the report was submitted rather than the date the initial reporter provided the information about the event to the company.Corrective action has been taken to clarify which date should be provided in the report.This supplemental report is intended only to correct the date provided in block b4 to reflect the date the initial reporter provided the information about the event to the company.

• Brand Name: ASAHI 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: 7657503
• MDR Text Key: 112994568
• Report Number: 3003775027-2018-00126
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 04547327108942
• UDI-Public: (01)04547327108942(17)210131(30)1(10)180208K05A
• 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
• Type of Report: Initial,Followup
• Report Date: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: CRV135-19P
• Device Lot Number: 180208K05A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 73