MAUDE Adverse Event Report: KANEKA CORPORATION SENRI; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number BD-S4080L

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

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

Event Date 07/30/2018

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 device history records (dhr) of the device concerned was reviewed: the production lot, to which the device concerned belongs, passed all in-process inspections including the visual test, shaft-pressurized test and the balloon-wrapping test for every product, and the finished product inspections including the shaft tensile strength test and the repetitive balloon inflation/deflation test on representative samples based on sampling plan.No nonconformity or abnormality in the manufacturing processes of the device concerned was found.The actual device concerned was returned and investigated: the fractured distal part including the balloon was not returned.The outer shaft was fractured at the 90 mm from the gw port.The inner shaft was fractured at the 45 mm from the gw port.The inner and outer shaft were torn from the guide wire (gw) port to the broken part.The core wire was moved 140 mm from the predefined position (in the hub) to the distal side.Probable cause(s) and our comment: the balloon should have been injured with a sharp edge of the calcified lesion or another device(s) concomitantly used and was ruptured when inflated.While retrieving it out of the patient, the bulky portion of the ruptured balloon was caught at the legion and became unable to pull back further.A further attempt to forcibly pull back the device resulted in breakage of the shaft including the balloon.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 device handling-issues.

Event Description

Arterial angiography, partly in co2 technique of the pelvic arteries and leg arteries on the left.Recanalization pta of the left superficial femoral artery recanalization pta of the left.Piii occlusion of the popliteal artery and the tibiofibular tibial artery on the left with complication of a material tear of the balloon catheter with retention in the superficial femoral artery left of (b)(6) 2018.The vascular surgery on (b)(6) 2018 went well.Dr.See the reason for the demolition in the difficult overall situation with elongation of the pelvic axis and the massive calcifications in closures of the afs and a.Poplitea.

• Brand Name: SENRI
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): KANEKA CORPORATION; 2-3-18; nakanoshima, kita-ku; osaka, osaka 530-8 288; JA 530-8288
• Manufacturer Contact: yoshiyuki kitamura ; 2-3-18; nakanoshima, kita-ku; osaka, osaka 530-8-288 ; JA 530-8288
• MDR Report Key: 7825886
• MDR Text Key: 118527508
• Report Number: 3002808904-2018-00016
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 08/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2018
• 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-S4080L
• Device Lot Number: SP096377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/06/2018
• 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): Hospitalization; Required Intervention