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

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.

• Brand Name: CROSSTELLA OTW
• Type of Device: CATHETER, 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 Key: 7742799
• MDR Text Key: 115807122
• Report Number: 3002808904-2018-00008
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 04540778162334
• UDI-Public: 04540778162334
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K160004
• 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: 07/05/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: BD-F50200LW
• Device Lot Number: SP028049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2018
• Initial Date FDA Received: 08/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2018
• 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): Life Threatening; Required Intervention
• Patient Age: 79 YR