MAUDE Adverse Event Report: KANEKA CORPORATION RX-GENITY; PTA BALLOON DILATATION CATHETER

Catalog Number RXGT-70040

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

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Date 10/19/2018

Event Type  Injury  

Manufacturer Narrative

The concerned device "rx-genity" is a rapid-exchange (rx) type semi-compliant pta balloon dilatation catheter compatible to 0.018" guidewire (gw)."rx-genity" 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 not returned, but we got the photo of the device: - the balloon of the catheter was torn off near the proximal end of the balloon.- the inner shaft was broken at the two points near the distal end of the balloon and near the guide wire port.The device history records (dhr) of the device concerned was reviewed: the dhr of the concerned device was reviewed and no nonconformity or abnormality in the manufacturing processes was found.Probable cause(s) and our comment: the balloon should have been injured by the stent strut or a sharp edge of the calcified lesion and was ruptured during being inflated.When the operator tried to retrieve the device out of the patient, the distal part of the ruptured balloon stuck at the lesion, and was broken apart by an excessive tensile strength.Then, further attempt to pull back the device torn off the inner shaft.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

Treatment of highly calcified iliac artery lesions with a degree of stenosis of 80 to 89%.When using the balloon catheter, rx-genity(7.0mm×40mm), for a post-dilatation of the stent, the balloon ruptured without going up to rated burst pressure.The operator tried to retrieve the catheter, but the balloon was trapped.Somehow the operator pulled out, but the balloon and the inner shaft remained inside the body and they were difficult to retrieve.Since originally the artery was clogged from the iliac artery to the peripheral artery and was planned to carry out fp bypass, they were surgically recovered at the time of the elective operation.

• Brand Name: RX-GENITY
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): KANEKA CORPORATION; 2-3-18; nakanoshima, kita-ku; osaka-city, osaka 530-8 288; JA 530-8288
• Manufacturer Contact: yoshiyuki kitamura ; 2-3-18; nakanoshima, kita-ku; osaka-city, osaka 530-8-288 ; JA 530-8288
• MDR Report Key: 8049271
• MDR Text Key: 126506337
• Report Number: 3002808904-2018-00019
• 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: 10/19/2018

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: 07/31/2019
• Device Catalogue Number: RXGT-70040
• Device Lot Number: SP086504
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2018
• Initial Date FDA Received: 11/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2016
• 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): Life Threatening; Required Intervention