MAUDE Adverse Event Report: KANEKA CORPORATION SENRI CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL, PRODUCT CODE: LIT

Catalog Number BD-J3020L

Device Problems Use of Device Problem (1670); Device Handling Problem (3265)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/31/2020

Event Type  Injury  

Manufacturer Narrative

The concerned device subject to this reported event, "senri", an rx-type pta balloon catheter compatible with 0. 018" guidewire (gw), is not distributed in the us, however, we intend to report this case as the event occurred on one of the similar devices for "crosstella rx pta balloon dilatation catheter" distributed in the us under 510(k) # k152873. The device history records (dhr) of the device concerned was reviewed: no nonconformity or abnormality in the manufacturing processes of the device concerned was found. Results of the investigation on returned concerned device: no nonconformity or abnormality in the concerned device was found. Conclusion: it was speculated that the operation was caused by forgetting to remove the balloon protection tube and inserting it into the blood vessel.

Event Description

The product was used for pta for shunt stenosis. At that time, the procedure was completed without any problems, but due to repeated stenosis, a balloon protection tube was confirmed inside the body when confirmed by angio, echo, etc. The blood vessels were surgically opened and the protection tube was removed from the body.

• Brand Name: SENRI
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL, PRODUCT CODE: LIT
• Manufacturer (Section D): KANEKA CORPORATION; 2-3-18; nakanoshima, kita-ku; osaka-city, osaka 530-8 288; JA 530-8288
• Manufacturer (Section G): KANEKA CORPORATION OSAKA PLANT; 5-1-1; settsu-city; osaka, 56600 72; JA 5660072
• Manufacturer Contact: joji sengoku ; 1-12-32; akasaka; minato-ku, tokyo 10700-52 ; JA 1070052
• MDR Report Key: 11606851
• MDR Text Key: 243946863
• Report Number: 3002808904-2021-00005
• 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

• Type of Report: Initial
• Report Date: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 05/31/2022
• Device Catalogue Number: BD-J3020L
• Device Lot Number: SP069126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2019
• 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: 04/02/2021 Patient Sequence Number: 1