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

Catalog Number ZE-15-200

Device Problems Hole In Material (1293); Device Abrasion From Instrument Or Another Object (1387); Material Puncture/Hole (1504); Material Rupture (1546); Material Perforation (2205); Scratched Material (3020)

Patient Problems Intimal Dissection (1333); Vascular Dissection (3160)

Event Date 12/01/2017

Event Type  Injury  

Manufacturer Narrative

The actual device concerned was returned and investigated: a short deep scratch that edge penetrated the balloon was found at 19 mm from the distal tip of the device.Water leaked from the hole when the balloon was pressurized with water.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 or another device(s) concomitantly used, and was ruptured when inflated at the rbp.However, the causal relationship between the balloon rupture and the occurrence of vascular dissociation is not clear.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 not distributed in the u.S, 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 (2.00 mm x 15 mm), was employed for a ptca of the rca #3.The lesion was calcified chronic total occlusion (cto).Before performing a balloon dilatation, the lesion was crossed by a 0.014" gw, "sion blue" (asahi intecc, co.), through 8-fr guiding catheter (gc), "launcher" (medtronic plc) and 8.2-fr guiding sheath "super sheath" (medikit co.Ltd.).This balloon catheter was inserted into the lesion and dilated five (5) times.Then, this balloon catheter was replaced with another device (no information about the device was available), and then this device was re-crossed and inflated again at the rbp of 14 atm.Then, the balloon ruptured and a vascular dissection recognized by an angiogram occurred.A stent was placed over the dissociated area for bailout.

• 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: kazuhiko inoue ; 2-3-18; nakanoshima, kita-ku; osaka, osaka 530-8-288 ; JA 530-8288 ; 31814120
• MDR Report Key: 7137240
• MDR Text Key: 95453618
• Report Number: 3002808904-2017-00011
• Device Sequence Number: 1
• Product Code: LOX
• 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: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2020
• Device Catalogue Number: ZE-15-200
• Device Lot Number: SP107230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2017
• 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
• Patient Age: 64 YR
• Patient Weight: 55