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

Catalog Number DV15-08040RN

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/19/2017

Event Type  Injury  

Manufacturer Narrative

The concerned device "diva" is a rapid-exchange (rx) type semi-compliant pta balloon dilatation catheter compatible to 0.018" guidewire (gw)."diva" 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, and so on.The actual device concerned was returned and investigated.The balloon was ruptured transversely at 17 mm distal of the proximal radiopaque marker on the inner shaft, and the distal portion of the broken balloon with the tip of the catheter was missing.The inner shaft (the gw lumen) was broken apart, with remaining elongated and sheared off inner layer, at about 6 mm distal of the distal radiopaque marker.The distance between the distal and the proximal radiopaque markers was 40 mm, as was its original, and no elongation of the inner shaft till the broken point was observed.Accordingly, about 3 cm long including the tip and the broken balloon portion is possibly remained in the patient's vessel.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 injured when it was moved and inflated in the stent, and the balloon ruptured due to the load of the third inflation.When the catheter was tried to pull out of the patient, the distal part of the broken balloon stuck in the stent and was broken apart by an excessive tensile strength.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 "diva", a pta balloon dilatation catheter, was used for the post-dilatation of 10 x 40 mm "epic" stent (boston scientific (b)(4)) placed at the lesions in the cia and the eia.In the first inflation at 12 atm (the rated balloon-burst pressure (rbp) of this balloon), about 1 cm long of the proximal part of the balloon did not inflate completely.The balloon was deflated to pull back about 1 cm to the proximal and inflated again at 12 atm, however, the balloon inflated still incompletely.The balloon was deflated to pull back another about 1 cm and inflated there again at 12 atm.During this third inflation, the balloon ruptured.When the catheter was removed from the patient, about 2 cm of the distal part of the balloon was missing and the tip was looked slightly extended.After removing the guidewire (gw) out of the patient, the broken part of the balloon was tried to recover out of the patient by using a 3fr biopsy-forceps for myocardium, and then by a snare device, however it was failed to capture the broken balloon since the whereabouts of it could not be located.Then, the broken part was searched by an ivus catheter introduced into the iliac arteries and then by a x-ray fluoroscopy of the whole right leg, however, the broken balloon could not be found.The targeted lesion was confirmed dilated as intended by the x-ray image, the patient alleged no sense of discomfort, and the procedure was completed with the broken balloon portion possibly remained in the patient's vessel.

• Brand Name: DIVA
• 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: 6713251
• MDR Text Key: 80011016
• Report Number: 3002808904-2017-00001
• 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: 06/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: DV15-08040RN
• Device Lot Number: SP036061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2016
• 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
• Patient Age: 69 YR