MAUDE Adverse Event Report: KANEKA CORPORATION KANEKA PTA CATHETER PE-R3, RX-GENITY; PTA BALLOON DILATATION CATHETER

Catalog Number RXGT-30020

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/27/2017

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, and so on.Since the concerned device used was not returned to the manufacturer, the dhr of the device with the lot no.Sp077289 was reviewed, and no nonconformity or abnormality in the manufacturing processes was found.The lot passed all in-process inspections including the balloon folded-shape check, the guidewire lumen integrity test and the shaft-pressurized test for every product, and the finished product inspections including the balloon-repetitive inflation/deflation test and the shaft tensile strength test on representative samples based on the sampling plan.The balloon portion of the rx-genity is protected with a balloon protective tube inserted over the balloon and a stylet inserted into the guidewire lumen, and the stylet and the balloon protective tube are instructed to be removed before use.It is obvious that the rx-genity was inserted into the patient's vessel with the balloon protective tube unremoved, hence the balloon could not be inflated, and the balloon protective tube came off while the catheter was pulled back and remained in the patient's vessel.We determined that the reported event was caused by not a defect or malfunction of the device but by a device handling issue.

Event Description

This pta balloon catheter was used for a pre-dilatation of the carotid artery stenosis.The device was delivered into the lesion and was attempted to dilate the lesion, but the balloon could not be expanded.Then, the device was once removed from the guiding catheter (gc) and inserted again.It was found that the balloon protection tube of the device had come off and remained in the patient's vessel.By a postoperative imaging, the location of the balloon protection tube in the vessel was confirmed.The physician tried but failed in retrieving it by using a snare device, and crimped it with a stent to complete the procedure.

• Brand Name: KANEKA PTA CATHETER PE-R3, 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: kazuhiko inoue ; 2-3-18; nakanoshima, kita-ku; osaka-city, osaka 530-8-288 ; JA 530-8288 ; 31814120
• MDR Report Key: 7124791
• MDR Text Key: 95180047
• Report Number: 3002808904-2017-00009
• 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: 11/28/2017

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: 06/30/2020
• Device Catalogue Number: RXGT-30020
• Device Lot Number: SP077289
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2017
• Initial Date FDA Received: 12/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2017
• 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