MAUDE Adverse Event Report: KANEKA CORPORATION SHIRANUI EX; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number SE45-5040

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 07/07/2018

Event Type  Injury  

Manufacturer Narrative

The actual device concerned was returned and investigated: the distal torn off portion of the balloon with the distal tip and the proximal portion from the balloon were returned.The balloon was ruptured and broken at 4 cm from the distal tip.The inner-shaft (the guidewire lumen) was elongated and torn off at the welded portion with the distal 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 should have been injured by hardened and sharp edge of the lesion, and was ruptured when the balloon was inflated.While retrieving it out of the patient, the bulky portion of the ruptured balloon was caught at the anastomotic region and became unable to pull back further.A further attempt to forcibly pull back the device resulted in breakage of the balloon and the inner-shaft, and the broken fragment remained in the patient's vessel.No nonconformity was found in the manufacturing processes of the device concerned, and accordingly, we determine that the event reported was caused by not any defect of the device but the user's handling issues.

Event Description

[shiranui ex is a rapid-exchange type semi-compliant pta balloon catheter compatible with 0.018 inch guidewire].Shiranui ex 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." crosstella otw" (otw type pta balloon dilatation catheter,0.018" guidewire compatible) in us under 510(k)# k160004."" crosperio otw" (otw type pta balloon dilatation catheter,0.014" guidewire compatible) in us under 510(k)# k160013." balloon rupture occurred at about 14 atm when it was repeatedly dilated in the elbow vein by percutaneous shunt dilatation.When it was pulled out, the tip of the catheter broke and remained in the body.Under fluoroscopy, the tip could not be found in the patient's body.However, because there is no health damage and dialysis can be done, the operator decided to complete the procedure and to remove the tip when the next operation on the replacement of the artificial blood vessel would be performed.After 10 days, when the artificial blood vessel was indwelled, the distal end portion left in the body was found near the anastomotic site and it was removed.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." crosstella otw" (otw type pta balloon dilatation catheter,0.018" guidewire compatible) in us under 510(k)# k160004."" crosperio otw" (otw type pta balloon dilatation catheter,0.014" guidewire compatible) in us under 510(k)# k160013." balloon rupture occurred at about 14 atm when it was repeatedly dilated in the elbow vein by percutaneous shunt dilatation.When it was pulled out, the tip of the catheter broke and remained in the body.Under fluoroscopy, the tip could not be found in the patient's body.However, because there is no health damage and dialysis can be done, the operator decided to complete the procedure and to remove the tip when the next operation on the replacement of the artificial blood vessel would be performed.After 10 days, when the artificial blood vessel was indwelled, the distal end portion left in the body was found near the anastomotic site and it was removed.

• Brand Name: SHIRANUI EX
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): KANEKA CORPORATION; 2-3-18; nakanoshima,kita-ku; osaka -city,osaka 530-8288,ja,
• Manufacturer (Section G): YOSHIYUKI KITAMURA
• Manufacturer Contact: yoshiyuki kitamura ; naknoshima,kita-ku; osaka-city; osaka 530-8288, ; JA
• MDR Report Key: 7757471
• MDR Text Key: 116257223
• Report Number: 3002808904-2018-00012
• 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: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: SE45-5040
• Device Lot Number: SP077249
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/04/2017
• 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; Required Intervention
• Patient Age: 86 YR
• Patient Weight: 47