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

Catalog Number BD-S2060L

Device Problems Material Separation (1562); Material Integrity Problem (2978); Device Handling Problem (3265)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/09/2015

Event Type  malfunction  

Manufacturer Narrative

The device history records (dhr- batch record) of the senri with lot no.Sp114109 was reviewed and no nonconformity or abnormality in the manufacturing processes was found.The lot passed all in-process inspections including the balloon-repetitive inflation/deflation test, the shaft-pressurized test for every product and the finished product inspections including shaft tensile strength test on representative samples based on sampling plan.The concerned used device senri was returned and investigated: the balloon and the inner shaft (the guidewire lumen) with the distal tip were torn off and was missing from the returned senri.A trace of scratch extended in the direction of the catheter-long axis was observed on the balloon outer surface closer to the torn off edge.The nominal catheter-effective length (from the distal end to the neck of the strain relief) of this senri (catalogue # bd-s2060l) is 1,500 mm.The length from the edge of torn off inner shaft with the torn off balloon to the neck of the strain relief was 1,528mm, and accordingly, the remained catheter shaft was elongated by at least 30 mm.The balloon-effective length (from the distal shoulder to the proximal shoulder, or between both radiopaque markers) is 60 mm.The balloon was torn off at about 26 mm from the proximal shoulder, and accordingly, approximately 4 cm of the distal portion (including the distal tip through the torn off-inner shaft with a radiopaque marker and the torn off-balloon portion) should be remained in the patient's vessel.Probable cause and comments: we speculate the reported situation as follows: 1) the balloon of the senri was injured and raptured while passing through and inflating in the heavily calcified cto lesion, 2) the bulky distal portion of the ruptured balloon became difficult to be pulled back for retrieving the device out of the patient, and then, 3) further attempts to withdraw forcibly the senri tore off the balloon and the inner shaft, and the torn off distal portion of the senri was separated and remained in the lesion of the patient's vessel.The reported problem is determined not to be caused by any defect of the device.This report is delayed because it was sent to the emdr test instead of production.

Event Description

The concerned device "senri" (rx-type pta balloon dilatation catheter, 0.018" guidewire compatible) is not distributed in us.However, we intend to report this case as the event occurred on the similar device for "metacross rx" (rx-type pta balloon dilatation catheter, 0.035" guidewire compatible) that is distributed in us under 510(k) # k150865.An intervention of the sfa and poplitea ((b)(6)).Crossover access point at right leg.They used a destination 45 cm 6fr.Target vessel was cto of the a.Tibialis, highly calcified.After dilatation of the left sfa, without any problems, they switched from a 0.035" standard hydrophilic guidewire to glidewire advantage (gwa) 0.018", 300 cm.Recanalization of the cto with the gwa.After recanalization, the concerned device "senri" was inserted, first dilatation with a 10 ml syringe (no inflation/deflation device) was performed, withdrawn of the senri and then angiography over the destination was done.The physician saw a rest stenosis and decided to do a second dilatation, again, using the 10 ml syringe for inflation of the senri.During this second inflation, the balloon of the senri burst.The physician tried to withdraw the senri, however, he felt a resistance.After that while removing the device with the guidewire, the tip of the balloon (tip with distal marker) was torn off.A part of the balloon remained in the leg.It was not possible to remove it with a goose neck.The patient is very old and has very good collaterals, and the physician decided to leave the torn off balloon portion as it was in the patient's vessel.More details on 12/14/2015: according to the physician in charge, the patient is well and she might not need a surgery to remove the broken balloon part.

• Brand Name: SENRI
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): KANEKA CORPORATION; 2-3-18, nakanoshima, kita-ku,; osaka-city, 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 ; 4613072
• MDR Report Key: 6203725
• MDR Text Key: 63621644
• Report Number: 9614654-2016-00002
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: BD-S2060L
• Device Lot Number: SP114109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2014
• 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
• Treatment: DESTINATION 45 CM 6FR; GLIDEWIRE ADVANTAGE (GWA) 0.018", 300 CM
• Patient Outcome(s): Other
• Patient Age: 86 YR
• Patient Weight: 80