MAUDE Adverse Event Report: KANEKA CORPORATION CROSPERIO RX; CROSPERIO RX PTA BALLOON DILATATION CATHETER

Catalog Number BD-B20200LR

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 05/24/2017

Event Type  Injury  

Manufacturer Narrative

The actual device concerned was returned and investigated: the balloon with 200mm in length originally was torn off at about 148mm from the proximal end of the balloon.The balloon was transversely split around a half, as if it was cut with a sharp knife, and the remaining half was sheared off to completely split.The inner shaft (the gw lumen) was elongated by more than 5 cm, but the whole length till the distal tip portion remained in the device returned.The distal portion of the broken balloon was ripped away from the inner shaft with debris of the welded part remained on the shaft.A portion of the balloon ripped away and remained in the patient was calculated about 5cm in length, accordingly.The distal radiopaque ring-marker mounted on the inner shaft was not remained on the elongated inner shaft, and its whereabouts is unknown.It might be possible being remained in the patient.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, where it broke apart, was injured by a sharp edge of the calcified lesion after dilated with a cutting balloon, and it ruptured transversely from the injury when inflated in the lesion.When the physician tried to retrieve the device, the distal part of the balloon, bulky with the rupture, was trapped in the lesion.Further attempt to pull out the device forcibly with the distal portion trapped in the lesion elongated the shaft, and finally the balloon portion trapped in the lesion was ripped away from the shaft, and the device came out of the patient's vessel with the distal potion of the balloon remained in the lesion.The radiopaque ring-marker dismounted from the elongated and slenderized shaft dropped off through the distal tip of the shaft after the distal balloon portion was ripped away out of the shaft, while the device was pulled out of the patient.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

This device, "crosperio rx" pta balloon dilatation catheter (2.0mm x 200mm), was employed for a pta of the posterior tibial artery.The patient's profile in detail was not available.The lesion was calcified.Before performing a balloon dilatation, the lesion was crossed by 0.014" guidewire (gw), "gladius" (asahi intecc, co.), through 6-fr guiding sheath, "destination" (terumo, co.).Then, the gw was replaced with another 0.014" gw, "cruise" (asahi intecc, co.), and the lesion was balloon-dilated consecutively with "jade 1.5mm x 80mm" (orbusneich medical, inc.), this device, a cutting balloon 3.0mm x 80mm (the manufacturer unknown), and then with this device again.The balloon of this device ruptured in the second use.The physician tried to retrieve this device out of the patient, but the distal portion of the balloon got stuck in the lesion.Further attempt to pull out the device resulted in torn off the distal portion of the balloon which remained in the patient's vessel.The physician tried but failed to retrieve the torn off balloon portion by using another catheter device, and pressed to fix it onto the vessel's wall by using a stent to complete the procedure.

• Brand Name: CROSPERIO RX
• Type of Device: CROSPERIO RX PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): KANEKA CORPORATION; 2-3-18; nakanoshima,kita-ku,; osaka-city, osaka 530-8 288; JA 530-8288
• Manufacturer Contact: kazuhiko inoue ; 2-3-18; nakanoshima, kita-ku; osaka-city, osaka 530-8-288 ; JA 530-8288 ; 31814120
• MDR Report Key: 6662463
• MDR Text Key: 78231275
• Report Number: 9614654-2017-00009
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 04540778163430
• UDI-Public: 04540778163430
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K152887
• 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: 05/24/2017

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: 01/31/2019
• Device Catalogue Number: BD-B20200LR
• Device Lot Number: SP036246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/24/2017
• Initial Date FDA Received: 06/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2016
• 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