MAUDE Adverse Event Report: KANEKA CORPORATION METACROSS RX PTA BALLOON DILATATION CATHETER; CATHETER, PERCUTANEOUS

Catalog Number BD-L70200CR

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 02/01/2019

Event Type  Injury  

Manufacturer Narrative

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 for every product, and the finished product inspections on representative samples based on sampling plan.No nonconformity or abnormality in the manufacturing processes of the device concerned was found.The actual device concerned was returned and investigated: the proximal end of the catheter was cut.The balloon was broken at 40mm from the proximal shoulder of the balloon.The inner shaft and outer shaft were elongated or cut.The distal radiopaque marker was missing.Probable cause(s) and our comment: the balloon should have been injured by an edge of the stent strut and was ruptured during being inflated.In order to deflate the balloon that had inflated, the concerned device was retract into the child catheter, so the balloon was caught at the breakage part on the tip of the child catheter and was broken.The broken fragment of the balloon remained inside the blood vessel.No non-conformity 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

In-stent restenosis (occlusion) lesion.Using a guiding sheath and a 0.014 inch guide wire, after the catheter passed through the lesion the balloon was dilated, but it was ruptured at 14 atm.The child catheter (the catheter thinner than the guiding sheath) could be placed in the guiding sheath.Because the balloon of the catheter was a little inflated, it attempted to retract into the child catheter to deflate the balloon, but it could not be done.Ultimately, the distal end of the balloon broke, and the broken fragment remained in the patient's vessel.The fragment was fixed to the vessel wall with the stent.

• Brand Name: METACROSS RX PTA BALLOON DILATATION CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): KANEKA CORPORATION; 2-3-18; nakanoshima, kita-ku; osaka-city, osaka 53082 88; JA 5308288
• Manufacturer Contact: yoshiyuki kitamura ; 2-3-18; nakanoshima, kita-ku; osaka-city, osaka 53082-88 ; JA 5308288
• MDR Report Key: 8388929
• MDR Text Key: 137795353
• Report Number: 3002808904-2019-00003
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 04540778153110
• UDI-Public: 04540778153110
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K150865
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date: 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: BD-L70200CR
• Device Lot Number: SP046435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2016
• 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): Other