MAUDE Adverse Event Report: KANEKA CORPORATION SHIRANUI EX; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number SE45-5040

Device Problems Break (1069); Material Fragmentation (1261); Device Handling Problem (3265)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/22/2016

Event Type  malfunction  

Manufacturer Narrative

The "shiranui ex" is an otw - type semi-compliant pta balloon dilatation catheter compatible to 0.018" guidewire (gw) and has no approval in usa.We intend to report this case as the event occurred on the similar device for "metacross otw" (otw-type pta balloon dilatation catheter, 0.035" gw-compatible) distributed in us under 510(k) # (b)(6), "and so on.The device history record (dhr) of the shiranui ex with lot no.Sp125315 was reviewed and no nonconformity or abnormality was found in its manufacturing processes.The device met its material, assembling and product specifications.The concerned actual device used was returned and was investigated.The distal torn off portion of the balloon with the distal tip, and the proximal portion from the balloon- and the shaft-torn off position till the proximal end (hub-parts) of the catheter were returned.The balloon was torn off at c.A.35mm from the distal edge.A trace of rupture extended in the direction of the balloon long axis was observed at the torn off edge of both distal and proximal portions of the balloon, which suggested that the balloon burst while it was inflated with a visual observation, no missing fragment of the device was noticed.The physician commented that he continued pressurized the balloon till it ruptured while the gauge of the inflation device could not move at 14atm.Accordingly, it was possible that the balloon was pressurized to exceeding its rated burst pressure (rbp) at 22atm to burst.Probable cause and comments: we speculate the reported situation as follows: 1) the balloon burst with pressurized over the rbp, 2) the bulky balloon potion with the rupture was trapped at the lesion or the orifice of the sheath device while trying to retrieve it out of the patient, and 3) the balloon and the catheter shaft was torn off with excessive tensile force by forcibly pull out the device.In conclusion, the reported problem is determined not to be caused by any defect of the device.This report is delayed because it was sent to the emdr test instead of production.

Event Description

This over the wire (otw) - type pta balloon catheter (product name: "shiranui ex") was used for the dilatation of a dialysis-shunt anastomotic stenosis.At the fourth attempt to dilate the lesion with this balloon, the physician noticed that the gauge of the inflation device did not move at 14 atm.Nevertheless, he continued pressurizing the balloon with the inflation device, and then the balloon ruptured.While retrieving the catheter from the patient, the distal portion of the balloon with the shaft was torn off and remained in the patient's blood vessel.The torn off portion remained in the patient's blood vessel was removed surgically by cutting open the blood vessel.

• Brand Name: SHIRANUI EX
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): KANEKA CORPORATION; 2-3-18, nakanoshima, kita-ku,; osaka-city, 530-8 288; JA 530-8288
• Manufacturer Contact: kazuhiko inoue ; 2-3-18; nakanoshima, kita-ku; osaka, osaka 530-8-288 ; JA 530-8288 ; 4613072
• MDR Report Key: 6203726
• MDR Text Key: 63264623
• Report Number: 9614654-2016-00004
• 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: 01/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: SE45-5040
• Device Lot Number: SP125315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2016
• Initial Date FDA Received: 12/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2015
• 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
• Treatment: DISPOSABLE INFLATION DEVICE.(MAKES UNKNOWN)
• Patient Outcome(s): Required Intervention