MAUDE Adverse Event Report: KANEKA CORPORATION KANEKA PTCA CATHETER CO-R7(IKAZUCHI ZERO); CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Catalog Number ZE-15-250

Device Problems Material Puncture/Hole (1504); Material Perforation (2205)

Patient Problems Perforation (2001); Vascular Dissection (3160)

Event Date 07/29/2019

Event Type  Injury  

Manufacturer Narrative

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.Probable cause(s) and our comment: the balloon should have been injured with a sharp edge of the calcified lesion, and was ruptured when inflated at 14 atm.No nonconformity or abnormality in the manufacturing processes of the device concerned was found, and accordingly, we determine that the event reported was caused by not any defect of the device.

Event Description

The concerned device subject to this reported event, "ikazuchi zero", an rx-type ptca balloon catheter compatible with 0.014" guidewire (gw), is no distributed in the us, however, we intend to report this case as the event occurred on one of the similar devices for "rx takeru ptca balloon dilatation catheter" distributed in the us under 510(k) # k163372.This ptca balloon catheter (2.50 mm x 15 mm) rupture occurred during pre-dilatation at 14 atm for the calcified lesion at the medium of the lad (left anterior descending branch), resulting in vascular perforation and transient vascular dissection.Des was placed to cope with perforation and vascular dissection, and pci was successfully completed.Later, the patient recovered and was discharged.

• Brand Name: KANEKA PTCA CATHETER CO-R7(IKAZUCHI ZERO)
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): KANEKA CORPORATION; 2-3-18; nakanoshima, kita-ku; osaka, osaka, 530-8 288; JA 530-8288
• Manufacturer Contact: yoshiyuki kitamura ; 2-3-18; nakanoshima, kita-ku; osaka, osaka, ja 530-8-288 ; JA 530-8288
• MDR Report Key: 8913856
• MDR Text Key: 159357095
• Report Number: 9614654-2019-00022
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 08/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: ZE-15-250
• Device Lot Number: SP049423
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2019
• 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): Required Intervention