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

Catalog Number CH45-5040

Device Problems Material Rupture (1546); Material Separation (1562); Use of Device Problem (1670); Device Handling Problem (3265)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/05/2018

Event Type  Injury  

Manufacturer Narrative

Results of investigations: the concerned device used was returned and investigated: the device returned consisted of the distal tip with the broken balloon fragment and the catheter shaft from the distal torn off portion through the intact manifold (the proximal end) of the device. The balloon was broken at 3 cm from the distal tip. The inner-shaft (the guidewire lumen) was elongated and torn off at the welded portion with the distal tip. The distal radiopaque marker was dislodged from the torn off inner-shaft and was missing, which was suspected to remain in the patient's vessel. 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 balloon should have been injured by hardened and sharp edge of the lesion, and was 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 stuck there. Further attempts to pull back the device forcibly resulted in torn off of the balloon and the inner-shaft to remain the broken fragment in the patient's vessel. 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. The balloon ruptured after several dilations in the lesion. The physician tried to retrieve the balloon catheter, however, the bulky part of the ruptured balloon could not enter into the sheath device and a strong resistance to pull back further was encountered. A further attempt to forcibly pull back the balloon catheter resulted in torn apart of the balloon portion and a broken fragment remained in the patient's blood vessel. The physician tried but could not locate the fragment in the patient's vessel, and completed the procedure with it remained in the patient.

• 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: yoshiyuki kitamura ; 2-3-18, nakanoshima, kita-ku; osaka, 530-8-288 ; JA 530-8288 ; 2265138
• MDR Report Key: 7467415
• MDR Text Key: 106695830
• Report Number: 3002808904-2018-00007
• 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,u

Reporter Occupation

• Type of Report: Initial
• Report Date: 04/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 12/31/2020
• Device Catalogue Number: CH45-5040
• Device Lot Number: SP018414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2018
• 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: 04/26/2018 Patient Sequence Number: 1