MAUDE Adverse Event Report: KANEKA CORPORATION SHIDEN; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL, PRODUCT CODE: LIT

Catalog Number SD-60040

Device Problems Material Separation (1562); Use of Device Problem (1670); Device Handling Problem (3265)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/24/2020

Event Type  Injury  

Manufacturer Narrative

The concerned device "shiden" is a rapid-exchange (rx) type semi-compliant pta balloon dilatation catheter compatible to 0.014" guidewire (gw)."shiden" has no approval in the us, however, we will report this case as an incident occurred on a similar device for "crosperio rx" (a rx-type pta balloon dilatation catheter, compatible to 0.014" gw) that is distributed in the us under 510(k) # k152887.Since the actual device was not retuned, we investigated the device history records.The device history records (dhr) of the device concerned was reviewed: the production lot, to which the device concerned belongs, passed all in-process inspections including the visual test, shaft pressurized test and the balloon-wrapping test for every product, and the finished product inspections including the shaft tensile strength test and the repetitive balloon inflation/deflation test on representative samples based on sampling plan.No nonconformity or abnormality in the manufacturing processes of the device concerned was found.No nonconformity or abnormality was found in the manufacturing processes according to the dhr.We believe the reported problem would not be caused by any defect of the device.

Event Description

Since sfa ruptured during the evt of the patient who had the stent graft in the terminal aorta, the doctor approached with gc 55cm 7fr from brachial and placed "viabahn 7mm-50mm".Then, with "shiden 6mm-40mm", 5 minutes x 5 to 6 expansions were performed at 10 atm to stop the bleeding.After that, when he tried to pull back shiden, he felt a strong resistance, so he was pulling out gc, gw and shiden together, but the shaft broken and the balloon part remained in the body as it was.

• Brand Name: SHIDEN
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL, PRODUCT CODE: LIT
• Manufacturer (Section D): KANEKA CORPORATION; 2-3-18; nakanoshima, kita-ku; osaka-city, osaka 530-8 288; JA 530-8288
• Manufacturer Contact: joji sengoku ; 1-12-32; akasaka; minato-ku, tokyo 10700-52 ; JA 1070052
• MDR Report Key: 10256477
• MDR Text Key: 198320103
• Report Number: 3002808904-2020-00014
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: SD-60040
• Device Lot Number: SR040434
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2020
• 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): Other