MAUDE Adverse Event Report: OHICHO3; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number CH75-6040

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 05/31/2019

Event Type  malfunction  

Manufacturer Narrative

The balloon of the catheter was broken circumferentially about 2 cm from the tip.The distal side of the broken balloon was caught on the orifice of the sheath.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 should have been injured at the hard and sharp end of the combined device or lesion and broken when the balloon was ruptured.While retrieving it out of the patient, the bulky portion of the ruptured balloon was caught at the anastomotic region and became unable to pull back further.No nonconformity was found in the manufacturing processes of the device concerned, 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

Ohicho 3 is an otw-type pta balloon catheter compatible with 0.035 inch guidewire.Ohicho 3 has no approval in usa.However, we intend to report this case as the event occurred on the similar device for "metacross otw" (otw type pta balloon.Dilatation catheter, 0.035" guidewire compatible) in us under 510(k)# (b)(4)", crosstella otw" (otw type pta balloon.Dilatation catheter,0.018" guidewire compatible) in us under 510(k)# (b)(4), and "crosperio otw" (otw type pta balloon.Dilatation catheter,0.014" guidewire compatible) in us under 510(k)#(b)(4)." the anastomotic stenosis was dilated several times with the catheter.Next, the stenosis just above the anastomotic site was dilated at 20 atm.At that time, the balloon of the catheter was ruptured.The operator tried to withdraw the catheter through the sheath but could not.The skin was dissected , and the catheter and the sheath were removed together.

• Brand Name: OHICHO3
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer Contact: yoshiyuki kitamura ; osaka, naknoshima,kita-ku 530-8-288 ; JA 530-8288
• MDR Report Key: 8742811
• MDR Text Key: 213934910
• Report Number: 3002808904-2019-00014
• 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: 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: CH75-6040
• Device Lot Number: SP039306
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2019
• 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