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

Catalog Number BD-J8040L

Device Problems Material Separation (1562); Use of Device Problem (1670); Device Handling Problem (3265)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 03/08/2018

Event Type  Injury  

Manufacturer Narrative

The concerned device "senri" is a rapid-exchange (rx) type semi-compliant pta balloon dilatation catheter compatible to 0.018" guidewire (gw)."senri" has no approval in the us, however, we will report this case as an incident occurred on a similar device for "crosstella rx" (a rx-type pta balloon dilatation catheter, compatible to 0.018" gw) that is distributed in the us under 510(k) # k152873.The actual device concerned was returned and investigated.The balloon was ruptured and broken at 41 mm from the distal tip.The inner shaft was elongated and broken, but the distal and the proximal radiopaque markers fixed on the inner shaft remained.The catheter shaft near the proximal balloon welded portion was elongated and deformed to occlude the balloon inflation lumen.Probable cause(s) and our comment: after the balloon dilatation of the stent, an excessive tensile force should have applied to the catheter shaft before the balloon was completely deflated, and the catheter shaft near the proximal balloon-welded part was elongated to occlude the balloon inflation lumen so that the balloon became impossible to further deflate.With further attempt to pull back the device forcibly, with the insufficiently deflated balloon portion stuck at the entrance of the sheath, the balloon portion was sheared apart, and then, the inner shaft was elongated to brake off.No nonconformity or abnormality in the manufacturing processes of the device concerned was found, 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

When the dr.Attempted to pull back this pta balloon dilatation catheter into the sheath after the post dilatation of a stent placed in the lesion, the balloon portion of this device could not enter into the sheath because the balloon was not completely deflated.The dr.Moved forward to release the balloon portion from the sheath, attempted to inflate and deflate the balloon, and tried but failed to pull back again into the sheath.The dr.Forcibly pulled back it further and then the balloon portion was torn apart and remained in the patient's blood vessel.A surgical operation was performed to remove the fraction of the balloon from the patient.

• Brand Name: SENRI
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): KANEKA CORPORATION; 2-3-18; nakanoshima, kita-ku; osaka-city, osaka 530-8 288; JA 530-8288
• Manufacturer Contact: kazuhiko inoue ; 2-3-18; nakanoshima, kita-ku; osaka-city, osaka 530-8-288 ; JA 530-8288 ; 31814120
• MDR Report Key: 7401676
• MDR Text Key: 104528451
• Report Number: 3002808904-2018-00002
• 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: 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: BD-J8040L
• Device Lot Number: SP027196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2017
• 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): Hospitalization; Life Threatening