MAUDE Adverse Event Report: KANEKA CORPORATION PTA BALLOON CATHETER(OHICHO3) PTA BALLOON DILATATION CATHETER

Catalog Number CH75-6040

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/04/2017

Event Type  Injury  

Manufacturer Narrative

Results of investigations: the concerned device used was returned and investigated: the balloon was cross-sectionally sheared apart at about 33 mm from the distal tip of the device, however, the whole catheter shaft including the distal tip remained. Trace of rupture in the longitudinal direction was observed at the sheared apart point in both side of the separated balloon. In the visual inspection, no fragment of the device seemed to have lost, and the device was entirely recovered out of the patient. Results of a review of the device history records (dhr): the dhr (batch record) of the device concerned was reviewed: the production lot, to which this particular 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 balloon repetitive 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 device was used for a dialysis shunt pta. The balloon should have been injured by hardened and sharp edge of the lesion, and ruptured when the balloon was inflated. While retrieving it out of the patient, the bulky portion of the ruptured balloon was caught at the ostium of the sheath and became unable to pull back further out of the patient. No nonconformity or abnormality in the manufacturing processes of the device concerned was found, and accordingly, we determine that the reported event was caused by not any defect of the device but the user's handling issues.

Event Description

The concerned device subject to this reported event "ohicho 3", an otw-type pta balloon catheter compatible with 0. 035" guidewire (gw), is not approved in us, however, we intend to report this case as the event occurred on one of the similar devices for "metacross otw", an otw-type pta balloon catheter compatible with 0. 035" gw, which is distributed in us under 510(k) #152080. This device "ohicho 3" (hereafter "balloon catheter") was employed for a dialysis-shunt pta. The balloon ruptured at the third dilations in the lesion. The physician tried to retrieve the balloon catheter through the sheath device, however, the bulky part of the ruptured balloon could not enter into the sheath and became unable to pull back further. Then, the balloon catheter together with the sheath device were removed by a surgical operation.

• Brand Name: PTA BALLOON CATHETER(OHICHO3)
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): KANEKA CORPORATION; 2-3-18,nakanoshima,kita-ku; osaka-city,osaka 530-8288; JA
• Manufacturer Contact: kazuhiko ; 2-3-18,nakanoshima,kita-ku; osaka, 530-8-288 ; 3184120
• MDR Report Key: 7145404
• MDR Text Key: 95725278
• Report Number: 3002808904-2017-00010
• 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: 12/04/2017

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

• Device Expiration Date: 09/30/2020
• Device Catalogue Number: CH75-6040
• Device Lot Number: SP117048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2017
• 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: 12/25/2017 Patient Sequence Number: 1