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

Catalog Number BD-J5020L

Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Use of Device Problem (1670); Device Handling Problem (3265)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/14/2018

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 longitudinally between 17 mm and 27 mm from the distal tip.The inner shaft was elongated and broken at 290 mm from the distal tip.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: since the "senri" was used as an anchor balloon to support delivering the other device, the catheter shaft was pulled to load a tension with the balloon inflated to fix in the patient's blood vessel.An excessive tensile force should have loaded 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 deflate.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

The parent sheath was attempted to engage from the left femoral artery to the renal artery, but it was blocked by the strut at the edge of a stent graft in the iliac artery and could not be engaged.Although the strut of the stent graft was extended by using this balloon catheter "senri" at about 5 atm for 3 times, but the sheath could not be engaged.After that, "senri" was inserted into the renal artery, it was used as an anchor balloon to support delivering the sheath, and the sheath was successfully engaged.While the dr.Tried to deflate the balloon of "senri" to remove it out of the patient, it became unable to deflate.The dr.Once pressurized the balloon to 20 atm and immediately decompressed naturally down to 14 atm.In 3 to 4 minutes, the pressure was naturally dropped to 5 atm, but the balloon was not possible to completely deflate.The dr.Engaged destination guiding-catheter from the left brachial artery to the renal artery and, ruptured the balloon of the "senri" by using a cutting balloon (2.5 mm x 15 mm), so the "senri" was successfully removed out of 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: 7401749
• MDR Text Key: 104527267
• Report Number: 3002808904-2018-00004
• 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: 03/14/2018

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: 08/31/2019
• Device Catalogue Number: BD-J5020L
• Device Lot Number: SP096386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2016
• 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