• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

KANEKA CORPORATION CROSSTELLA OTW CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number BD-F50200LW
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 07/03/2018
Event Type  Injury  
Manufacturer Narrative
The actual device concerned was returned and investigated: the balloon was torn off in two transversely at about 135 mm from the proximal shoulder. Furthermore, the balloon was broken off longitudinally for about 4. 9 mm. The inner shaft was torn off at about 52 mm from the broken part of the balloon. The two radiopaque markers were missing. The balloon-effective length (from the distal shoulder to the proximal shoulder, or between both radiopaque markers) is 200 mm. The balloon was torn off at about 135 mm from the proximal shoulder, and accordingly, approximately 120 mm of the distal portion (including the distal tip and the torn-off balloon portion with its inner shaft) should be remained in the patient's vessel. 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 otw tore off the balloon and the inner shaft, and the torn-off distal portion of the crosstella otw was separated and remained in the patient's vessel. 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
Crossover access 7f destination, occlusion distal afs to segment p1, recanalization with gwa 18, very heavily calcified vascular segment, subsequent dilatation of the recanalized area with the balloon, thereby bursting of the balloon. Upon withdrawal, it is noted that there is a detach of the 20 cm long balloon (about 5 cm distal) and remain in the patient. Subsequently, successful recanalization of the remaining balloon segment and overstenting with a supera.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCROSSTELLA OTW
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 Key7742799
MDR Text Key115807122
Report Number3002808904-2018-00008
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K160004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial
Report Date 07/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2021
Device Catalogue NumberBD-F50200LW
Device Lot NumberSP028049
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/18/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/06/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/04/2018
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: 08/02/2018 Patient Sequence Number: 1
-
-