MAUDE Adverse Event Report: KANEKA CORPORATION PTA BALLOON CATHETER(OHICHO3); PTA BALLOON DDILATATION CATHETER, PRODUCT CODE: LIT

Catalog Number CH45-6040

Device Problems Break (1069); Device Handling Problem (3265)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/16/2017

Event Type  Injury  

Manufacturer Narrative

Results of a review of the device history records (dhr): the dhr of the concerned device were checked by the reported lot number and the serial number: it was confirmed that the device passed all the in-process and the finished product inspections, e.G., the pressure tightness test, the balloon folding inspection, the appearance inspection, which are carried out in every product, and the balloon inflation test, the tensile strength test, conducted by representative sample.Probable cause(s): the balloon should have been injured by contacting with lesions, and ruptured when the balloon was inflated.While retrieving it out of the patient, the bulky part of the balloon due to the rupture was caught at the ostium of the sheath and became unable to pull back further out of the patient.Our comments: since no abnormalities or problems was found in the device history records (dhr), we determine that the reported problem was caused by not any defect of the device but the user's handling issues.

Event Description

The concerned device subject to this reported event, "ohicho 3" , an otw-type pta balloon catheter compatible with 0.035" guidewire (gw), is not distributed in us, however, we intend to report this case as the event occurred on one of the similar devices for "metacross otw", an otw-type pta balloon catheter compatible with 0.035" gw, which is distributed in us under 510(k) #152080.This "ohicho 3" pta balloon catheter (hereafter "balloon catheter") was employed for a dialysis-shunt pta.The balloon ruptured at the third dilations in the lesion.The physician tried to retrieve the balloon catheter through the sheath device, however, the bulky part of the ruptured balloon could not enter into the sheath and became unable to pull back further.Then, the patient was transferred to another facility and the balloon catheter together with the sheath device were removed by a surgical operation.

• Brand Name: PTA BALLOON CATHETER(OHICHO3)
• Type of Device: PTA BALLOON DDILATATION CATHETER, PRODUCT CODE: LIT
• Manufacturer (Section D): KANEKA CORPORATION; 2-3-18,nakanoshima,kita-ku; osaka-city,osaka 530-8288; JA
• Manufacturer Contact: kazuhiko ; 2-3-18,nakanoshima,kita-ku; osaka, 530-8-288 ; 3184120
• MDR Report Key: 7111854
• MDR Text Key: 94631794
• Report Number: 3002808904-2017-00007
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: CH45-6040
• Device Lot Number: SP067286
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2017
• 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): Required Intervention