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

Catalog Number	BD-B30080LR
Medical Device Problem Codes	Material Separation (1562); Use of Device Problem (1670); Device Handling Problem (3265)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual device concerned was not returned.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 injured on the delivery through the lesion and was ruptured while being inflated in the lesion.When the dr.Tried to retrieve the device, the bulky distal portion of the ruptured balloon was trapped in the lesion.Further attempts to pull back the device resulted in the fracture of the balloon and the device came out of the patient's vessels with the fractured balloon portion remained in the lesion.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 or Problem Description
The case was a pta on the lower extremity.The guidewire passed the lesion and the dr.Decided on pre-dilatation prior to stent placement.A 0.014 inch balloon catheter, the device concerned, was used.The balloon burst prior to complete inflation.The balloon catheter was removed but it was observed that some part of the balloon was missing.The fractured balloon portion was found at the lesion, and the dr.Tried but failed to remove it out of the lesion.A stent was advanced over area and deployed over the balloon fragment.A 0.035 inch balloon catheter was used for post stent dilatation, and the exam completed.

• Brand Name: CROSPERIO RX
• Common Device Name: CROSPERIO RX PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): KANEKA CORPORATION; 2-3-18; nakanoshima,kita-ku,; osaka-city, osaka 530-8 288; JA 530-8288
• MDR Report Key: 7081851
• Report Number: 3002808904-2017-00008
• Device Sequence Number: 1272537
• Product Code: LIT
• UDI-Device Identifier: 04540778163430
• UDI-Public: 04540778163430
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K152887
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: BD-B30080LR
• Device Lot Number: SP036144
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2017
• Initial Report FDA Received Date: 12/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Other
• Patient Age: 72 YR
• Patient Weight: 77