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U.S. Department of Health and Human Services

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

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KANEKA CORPORATION CROSSTELLA RX CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number BD-F25200LR
Device Problems Material Separation (1562); Use of Device Problem (1670); Device Handling Problem (3265)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 07/11/2018
Event Type  Injury  
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 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.
 
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Brand NameCROSSTELLA RX
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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 Key7757467
MDR Text Key116252108
Report Number3002808904-2018-00010
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K152873
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 07/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2019
Device Catalogue NumberBD-F25200LR
Device Lot NumberSP016044
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/31/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/19/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/16/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/07/2018 Patient Sequence Number: 1
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