MAUDE Adverse Event Report: KANEKA CORPORATION KANEKA PTCA CATHETER CO-R8 (TASUKI)

Catalog Number TS-16-200

Device Problem Material Fragmentation (1261)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/26/2020

Event Type  Injury  

Manufacturer Narrative

The concerned device subject to this reported event, "tasuki", an rx-type ptca balloon catheter compatible with 0.014" 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 "rx takeru ptca balloon dilatation catheter" distributed in the us under 510(k) # k163372.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.Results of the investigation on returned concerned device: during use, a balloon was dilated 14 times with pressure including exceeded rated burst pressure, and ruptured.A part of the balloon and the catheter (distal tip) reached the break by being load of the excessive pulling force in the severe calcified lesion.The length of the residual part inside the patient body was assumed approximately 16mm including distal tip, a radiopaque marker, and balloon.We concluded that the incident is determined not to be caused by any defect of the device, but to be caused by procedure/user.

Event Description

Tasuki was inserted into the severe calcified lesion and was dilated 14 times with pressure including exceeded rated burst pressure.While withdrawing the catheter, the physician felt some difficulty and resistance due to the severe calcification.The distal tip and a part of balloon could not be removed from the lcx lesion.

• Brand Name: KANEKA PTCA CATHETER CO-R8 (TASUKI)
• Type of Device: TASUKI
• Manufacturer (Section D): KANEKA CORPORATION; 2-3-18; nakanoshima, kita-ku; osaka-city, 530-8 288; JA 530-8288
• Manufacturer (Section G): KANEKA CORPORATION OSAKA PLANT; 5-1-1; torikai-nishi; settsu-city, osaka 566-0 072; JA 566-0072
• Manufacturer Contact: joji sengoku ; 1-12-32; akasaka; minato-ku, tokyo 107-6-028 ; JA 107-6028
• MDR Report Key: 10999736
• MDR Text Key: 221233076
• Report Number: 3002808904-2020-00022
• Device Sequence Number: 1
• Product Code: LOX
• 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: 11/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: TS-16-200
• Device Lot Number: SP128011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2018
• 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