MAUDE Adverse Event Report: KANEKA CORPORATION PTA BALLOON CATHETER S4, JACKAL RX; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number JKR 050 040 155

Device Problems Use of Device Problem (1670); Device Handling Problem (3265)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/16/2020

Event Type  Injury  

Manufacturer Narrative

The concerned device "jackal rx" is a rapid-exchange (rx) type semi-compliant pta balloon dilatation catheter compatible to 0.018" guidewire (gw)."jackal rx" has no approval in the us, however, we will report this case as an incident occurred on a similar device for "crosstella rx" (a rx-type pta balloon dilatation catheter, compatible to 0.018" gw) that is distributed in the us under 510(k) # k152873.The actual device concerned was returned and investigated.In the actual product, the fracture surface was a straight vertical balloon crack at about 30 to 38 mm from the tip, and the fracture surface was wavy circumferential tear at the 38 mm part.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.Probable cause(s) and our comment: the procedure information suggested that there was a possibility of being caught and ruptured by gc at the time of removal after rupture.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 but the user's handling issues.

Event Description

Balloon rupture occurred when using this product for shunt pta.There was resistance when attempting to withdraw, and when pulled out of the body, the balloon was torn and about 20 mm remained in the body.A new sheath was punctured and the balloon was recovered by surgical procedure using an ivus guide or snare.

• Brand Name: PTA BALLOON CATHETER S4, JACKAL RX
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): KANEKA CORPORATION; 2-3-18; nakanoshima, kita-ku; osaka, osaka 530-8 288; JA 530-8288
• Manufacturer Contact: tamiji fujimoto ; 2-3-18; nakanoshima,kita-ku; osaka, osaka 530-8-288 ; JA 530-8288
• MDR Report Key: 9697415
• MDR Text Key: 190326594
• Report Number: 3002808904-2020-00001
• 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: 01/17/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: JKR 050 040 155
• Device Lot Number: SP128046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/20/2020
• Initial Date FDA Received: 02/12/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2018
• 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