MAUDE Adverse Event Report: KANEKA CORPORATION SHIRANUI HP

Catalog Number SH75-5040

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 04/23/2020

Event Type  Injury  

Manufacturer Narrative

The actual device concerned was not returned, 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 may have damaged by the hardened sharp edge 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, and the broken pieces remained in the patient's blood vessel.

Event Description

Shiranui hp is an otw-type pta balloon catheter compatible with 0.018 inch guidewire.Shiranui hp has no approval in usa.However, we intend to report this case as the event occurred on the similar device for crosstella otw" (otw type pta balloon dilatation catheter,0.018" guidewire compatible) in us under 510(k)# k160004." the balloon rupture occurred when the balloon was repeatedly inflated.When it was pulled out, the tip of the catheter was broken.The tip of the catheter with distal part of the balloon broke have remained inside the body and it was removed.

• Brand Name: SHIRANUI HP
• Type of Device: SHIRANUI HP
• Manufacturer (Section D): KANEKA CORPORATION; 2-3-18; osaka, 530-8 288,; JA 530-8288,
• Manufacturer Contact: tamiji ; nakanoshima; kita-ku; osaka, 530-8-288
• MDR Report Key: 10064348
• MDR Text Key: 193306133
• Report Number: 3002808904-2020-00009
• 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: 04/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2020
• 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: SH75-5040
• Device Lot Number: SP039287
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2019
• 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): Life Threatening; Other