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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.
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Brand NameSENRI
Manufacturer (Section D)
nakanoshima, kita-ku
osaka-city, osaka 530-8 288
JA 530-8288
Manufacturer Contact
kazuhiko inoue
nakanoshima, kita-ku
osaka-city, osaka 530-8-288
JA   530-8288
MDR Report Key7401676
MDR Text Key104528451
Report Number3002808904-2018-00002
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
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 Received04/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2020
Device Catalogue NumberBD-J8040L
Device Lot NumberSP027196
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/13/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/09/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/28/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/05/2018 Patient Sequence Number: 1