MAUDE Adverse Event Report: KANEKA CORPORATION CROSSTELLA RX; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	BD-F25200LR
Medical Device Problem Codes	Material Separation (1562); Use of Device Problem (1670); Device Handling Problem (3265)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual device concerned was returned and investigated: the distal shaft was torn off at near the guidewire port, and the distal shaft from the broken part was missing.The outer shaft was elongated, and the proximal end of the core wire was misaligned forward.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 balloon was injured and ruptured while passing through and inflating in the heavily calcified lesion, the bulky distal portion of the ruptured balloon became difficult to be pulled back for retrieving the device out of the patient, and then, further attempts to withdraw forcibly the crosstella rx tore off the balloon and the inner shaft, and the torn-off distal portion of the crosstella rx was separated and remained in the patient's vessel.The cause of the guidewire port broken was not understood.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 or Problem Description
Dr.Reports the balloon ruptured during a challenging balloon angioplasty.There was significant calcification present.The balloon itself remained inside the artery.He placed a stent at the segment of the artery that had the balloon material present.

• Brand Name: CROSSTELLA RX
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): KANEKA CORPORATION; 2-3-18; nakanoshima, kita-ku; osaka-city, osaka 530-8 288; JA 530-8288
• MDR Report Key: 7757467
• Report Number: 3002808904-2018-00010
• Device Sequence Number: 16445053
• Product Code: LIT
• UDI-Device Identifier: 04540778159396
• UDI-Public: 04540778159396
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K152873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/12/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: BD-F25200LR
• Device Lot Number: SP016044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2018
• Initial Report FDA Received Date: 08/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention