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

Catalog Number CH45-5040

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 12/04/2019

Event Type  Injury  

Manufacturer Narrative

The catheter without distal part of the balloon was returned. The balloon portion was broken at about 1cm from the tip. 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 damaged by the hardened sharp edge of the anastomosis and should have been ruptured when the balloon was inflated. While removing it from the patient, the bulky portion of the ruptured balloon was caught on the sheath and could not be pulled back any more. Further attempts to forcibly pull back the device resulted in breakage of the balloon and the tip.

Event Description

Ohicho3 is an otw-type pta balloon catheter compatible with 0. 035 inch guidewire. Ohicho3 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)# k152080". The balloon rupture occurred when the balloon was repeatedly inflated at approximately 22 atm. When it was pulled out, the tip of the catheter was broken. The tip of the catheter with distal part of the balloon broke may have remained inside the body because it was not found.

• Brand Name: OHICHO3
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer Contact: tamiji fujimoto ; osaka, nakanoshima,kita-ku 530-8-288 ; JA 530-8288
• MDR Report Key: 9519173
• MDR Text Key: 189049412
• Report Number: 3002808904-2019-00033
• 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: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: CH45-5040
• Device Lot Number: SP079178
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2019
• 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: 12/26/2019 Patient Sequence Number: 1