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

Catalog Number CRV150-19P

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/29/2022

Event Type  Injury  

Manufacturer Narrative

Manufacturing site: (b)(4), registration number: (b)(4).The reported caravel microcatheter was returned for evaluation.Tip separation was confirmed on the returned caravel.Proximal to the torn end of the catheter tip, circumferential cracks caused by stretching of the tip were observed.Stretched inner jacket and the distal end of the braid tube were exposed at the torn end of the tip.These findings suggested that the tip was torn off at approximately 2mm from the distal end of the tip due to tensile stress.Lot history review revealed no anomaly relating to the reported event.No other similar product experience report was received from this lot.Based on the obtained information and investigation outcome, it was presumed that tensile stress generated with removal had contributed to the observed tip separation.As the catheter tip was being trapped in the calcified lesion, the applied stress would exceed the product design limit, causing the tip to be stretched and separated.It was concluded that this event was not attributed to product quality.Instructions for use (ifu) states: [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.) [malfunctions and adverse effects] separation.

Event Description

It was reported that a percutaneous coronary intervention (pci) was performed to treat a moderately tortuous, moderately calcified 90-99% stenosis in the segment #3 of the right coronary artery (rca).An asahi fielder xt-r guide wire crossed the lesion with the support of an asahi caravel microcatheter.As the unspecified devices used afterward were unable to be advanced over the fielder xt-r, the guide wire was then exchanged for an asahi grand slam guide wire.When attempting to remove the caravel after wire exchange, the catheter was felt like being caught.After removal, the tip of the caravel was found torn off.It was difficult to visually recognize the separated catheter tip under fluoroscopy.As there were no abnormal vital signs or chest symptom observed on the patient, the procedure was resumed and was successfully completed with reestablished blood flow achieved by stenting.The patient was reportedly fine after the procedure.

• 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
• 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: 16030403
• MDR Text Key: 305975713
• Report Number: 3003775027-2022-00169
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K152447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: CRV150-19P
• Device Lot Number: 200730K06A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2020
• 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): Disability