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

Model Number	BD-LX2040CR
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Deformation (2976)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 for every product, and the finished product inspections on representative samples based on sampling plan.No nonconformity or abnormality in the manufacturing processes of the device concerned was found.The actual device concerned was returned and investigated: the shaft of the product was cut, and only the tip side was returned.It was confirmed that the balloon 17 mm from the tip was deformed in a accordion shape, and that the balloon had three holes.It was confirmed that the shaft at 458 mm from the tip was cut near the gw lumen.From the tip to the gw lumen, the standard length is 400 �} 10 mm, and it was confirmed that it was stretched about 58 mm.There was no return of the proximal shaft.Probable cause(s) and our comment: the physician pulled the balloon into the sheath with insufficient deflation, or the balloon part was scratched due to strong contact between the hard lesion site and the balloon part, causing balloon rupture.It was presumed that the deflation was insufficient, which led to the possibility of being caught by the sheath and leading to difficult to removal.
Event or Problem Description
After placing a stent (14 mm x 40 mm) in aorta case, use the metacross rx(12 mm x 40 mm) for post-expansion.The doctor tried to remove it after deflation, but it caught on the sheath and could not be removed.After that, the shaft was cut, the sheath was replaced, and the product was removed by a surgical procedure.

• Brand Name: METACROSS RX PTA BALLOON DILATATION CATHETER
• Common Device Name: CATHETER
• Manufacturer (Section D): KANEKA CORPORATION; 2-3-18; nakanoshima, kita-ku; osaka-city, 53082 88; JA 5308288
• MDR Report Key: 9645467
• Report Number: 3002808904-2020-00002
• Device Sequence Number: 2767854
• Product Code: DQY
• UDI-Device Identifier: 04540778152397
• UDI-Public: 04540778152397
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150865
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/09/2020

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: 04/30/2022
• Device Model Number: BD-LX2040CR
• Device Catalogue Number: BD-LX2040CR
• Device Lot Number: SP059137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2020
• Initial Report FDA Received Date: 01/29/2020
• 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: Required Intervention