MAUDE Adverse Event Report: KANEKA CORPORATION PTA BALLOON CATHETER S4, JACKAL RX PTA BALLOON DILATATION CATHETER

Catalog Number JKR 080 040 155

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/18/2017

Event Type  Injury  

Manufacturer Narrative

The concerned device "jackal rx" is a rapid-exchange (rx) type semi-compliant pta balloon dilatation catheter compatible to 0. 018" guidewire (gw). "jackal rx" 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 cut transversely at near the proximal shoulder of the balloon. The inner shaft was torn off at the welded portion with the distal tip. The length of the lost portion, from the distal tip to the balloon-breaking part was estimated to be about 50 mm. Two radiopaque markers fixed on the inner shaft remained. The outer shaft was deformed in multiple positions. 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 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. Probable cause(s) and our comment: the balloon should have been injured by a sharp edge of the calcified lesion and was ruptured during being inflated. When the dr. Tried to retrieve the device out of the patient, the distal part of the ruptured balloon stuck at the orifice of the sheath device, and was broken apart by an excessive tensile strength. Then, further attempt to pull back the device torn off the inner shaft at the welded portion with the distal tip. 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 lesion treated was an axillary vein with 75 to 90% stenosis, mildly calcified, and the vessel tortuosity was also mild. This balloon catheter was used for a balloon dilatation of the lesion. First, the balloon was inflated 4 times in the lesion at 12atm and for 30 seconds each. At the seventh dilatation, the inflation pressure could not elevate over 2 atm. Since a balloon rupture was suspected, the dr. Retrieved this balloon catheter out of the patient and found that a distal portion of the balloon was missing. The dr. Tried but could not locate the fragment of the balloon in the patient. Since the patient's condition was normal, the dr. Decided to leave it possibly remained in the patient and monitor the patient's condition.

• Brand Name: PTA BALLOON CATHETER S4, JACKAL RX
• 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: 7184788
• MDR Text Key: 97054827
• Report Number: 3002808904-2017-00014
• 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

• Type of Report: Initial
• Report Date: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 06/30/2020
• Device Catalogue Number: JKR 080 040 155
• Device Lot Number: SP087087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2017
• 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: 01/11/2018 Patient Sequence Number: 1