MAUDE Adverse Event Report: KANEKA CORPORATION SHIDEN; PTA BALLOON DILATATION CATHETER

Catalog Number SD-60020

Device Problems Material Fragmentation (1261); Material Separation (1562)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 12/06/2021

Event Type  Injury  

Event Description

Shiden (6.0mm x 20mm) was inflated for the stenotic lesion with severe calcified, however the balloon was ruptured.Then the balloon was caught on the lesion, and the balloon was broken when it was pulled out.The broken fragment could not be pull out by the snare.The broken fragment was left in the patient and was tackled to the vessel wall with a stent.

Manufacturer Narrative

The concerned device subject to this reported event, "shiden", an rx-type pta 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 "crosperio rx pta balloon dilatation catheter" distributed in the us under 510(k) # k152887.Please find below the results of our investigation.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 for every product, and the finished product inspections on representative samples based on sampling plan.No nonconformity or abnormality in the manufacturing processes of the device concerned was found.The concerned device was returned and investigated: we confirmed that a loss of about 5 mm at the distal tip and about 17 mm at the balloon.We confirmed that the balloon part was broken in the circumferential direction.We speculate the reported situation as follows: because it is used in calcified lesions, the rupture occurred because the balloon was damaged at the hard part of the lesion.Further, the operation was not possible at the lesioned part or the tip of the combined device (for example, gc), and when the catheter was removed from the stucked state, the balloon was broken by an excessive tensile force.This was considered a malfunction caused by the procedure.Neither the dhr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.

Manufacturer Narrative

The concerned device subject to this reported event, "shiden", an rx-type pta 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 "crosperio rx pta balloon dilatation catheter" distributed in the us under 510(k) # k152887.Please find below the results of our investigation.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 for every product, and the finished product inspections on representative samples based on sampling plan.No nonconformity or abnormality in the manufacturing processes of the device concerned was found.The concerned device was returned and investigated: we confirmed that a loss of about 5 mm at the distal tip and about 17 mm at the balloon.We confirmed that the balloon part was broken in the circumferential direction.We speculate the reported situation as follows: because it is used in calcified lesions, the rupture occurred because the balloon was damaged at the hard part of the lesion.Further, the operation was not possible at the lesioned part or the tip of the combined device (for example, gc), and when the catheter was removed from the "stucked" state, the balloon was broken by an excessive tensile force.This was considered a malfunction caused by the procedure.Neither the dhr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.

Event Description

Shiden (6.0mm x 20mm) was inflated for the stenotic lesion with severe calcified, however the balloon was ruptured.Then the balloon was caught on the lesion, and the balloon was broken when it was pulled out.The broken fragment could not be pull out by the snare.The broken fragment was left in the patient and was tackled to the vessel wall with a stent.

• Brand Name: SHIDEN
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): KANEKA CORPORATION; 2-3-18; nakanoshima, kita-ku; osaka, osaka 53082 88; JA 5308288
• Manufacturer (Section G): KANEKA CORPORATION OSAKA PLANT; 5-1-1; torikai-nishi; settsu, osaka 56600 72; JA 5660072
• Manufacturer Contact: joji sengoku ; 1-12-32 akasaka; minato-ku; tokyo 10760-28 ; JA 1076028
• MDR Report Key: 13173711
• MDR Text Key: 285923019
• Report Number: 3002808904-2022-00001
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K152887
• 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: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: SD-60020
• Device Lot Number: SR100568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2020
• 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