MAUDE Adverse Event Report: KANEKA CORPORATION KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)

Catalog Number ZE-15-300

Device Problem Material Fragmentation (1261)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/05/2020

Event Type  malfunction  

Manufacturer Narrative

The concerned device subject to this reported event, "ikazuchi zero", an rx-type ptca balloon catheter compatible with 0.014" guidewire (gw), is not 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.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 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.Results of the investigation on returned concerned device: the middle shaft was elongated and torn at the distal end of the proximal shaft (hypotube).The distal shaft to middle shaft was not returned and could not be investigated.We assume the cause of this as follows: during use, the distal tip, the balloon, and/or the gw lumen was caught by the lesion or the combination device etc., and when pulled forcibly the catheter was elongated and finally broken.We concluded that the incident is determined not to be caused by any defect of the device.

Event Description

Ikazuchi zero was inserted into the lesion in right coronary artery and was dilated.While withdrawing the catheter after dilation, the part of the catheter was stuck at the lesion and could not remove totally.The part of the balloon was left in the artery.No patient injury was reported.

• Brand Name: KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)
• Type of Device: IKAZUCHI ZERO
• Manufacturer (Section D): KANEKA CORPORATION; 2-3-18; nakanoshima, kita-ku; osaka-city, 530-8 288; JA 530-8288
• Manufacturer (Section G): KANEKA CORPORATION OSAKA PLANT; 5-1-1; torikai-nishi; settsu-city, osaka 566-0 072; JA 566-0072
• Manufacturer Contact: joji sengoku ; 1-12-32; akasaka; minato-ku, tokyo 107-6-028 ; JA 107-6028
• MDR Report Key: 11044196
• MDR Text Key: 222697606
• Report Number: 3002808904-2020-00023
• 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
• Reporter Occupation: 505
• Type of Report: Initial
• Report Date: 11/23/2020

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: 03/31/2023
• Device Catalogue Number: ZE-15-300
• Device Lot Number: SR040407
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/16/2020
• Initial Date FDA Received: 12/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2020
• 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