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

Catalog Number BD-E6015L

Device Problems Material Puncture/Hole (1504); Material Separation (1562); Device Handling Problem (3265)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Device Embedded In Tissue or Plaque (3165)

Event Date 12/08/2017

Event Type  Injury  

Manufacturer Narrative

The concerned device "senri ex" is a rapid-exchange (rx) type semi-compliant pta balloon dilatation catheter compatible to 0.018" guidewire (gw)."senri ex" 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 110 mm from the proximal shoulder of the balloon.The length of the lost portion, from the distal tip to the balloon-breaking part was estimated to be about 50 mm.The inner shaft was elongated and broken at 134 mm from the proximal shoulder of the balloon, and the distal radiopaque marker fixed on the inner shaft was lost.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 lesion, 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 deflate.The balloon was forcibly ruptured to deflate with a puncture needle, but the distal portion of the ruptured balloon was still too bulky and not drawn into the sheath device.With further attempt to pull back the device forcibly, the balloon 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

In order to perform a pta of the left sfa, a m-coat sheath, a destination guiding sheath and a cruise guidewire (gw) were passed the lesion from the right femoral artery, and then, this device "senri ex", a pta balloon dilatation catheter (6 mm x 150 mm), passed without problem.The balloon dilatation at 8 atm was successfully done, but after then it became impossible to deflate the balloon.The dr.Tried but failed to rupture the balloon by using a hard gw, and then, the dr.Punctured the balloon with a needle over the skin and sucked up the contrast media inside the balloon into a 50 cc syringe.Then, the dr.Attempted to retrieve the balloon catheter, but the ruptured balloon-portion could not enter the sheath.The dr.Cut off the hub-parts of this device and remove the sheath and insert a 9 fr sheath over the catheter shaft of this device to draw in the balloon-portion into the sheath.When this device was removed out of the patient, it was found that the distal portion of the balloon was sheared off and not returned.The dr.Tried but failed to remove the broken piece with a snare.Then, confirmed the position of the remained balloon-fragment by using a ivus, and fixed it on the vessel wall with a stent.

• Brand Name: SENRI EX
• 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: 7145330
• MDR Text Key: 95727020
• Report Number: 3002808904-2017-00012
• 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: 12/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/25/2017
• 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: BD-E6015L
• Device Lot Number: SP087032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2017
• 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): Required Intervention