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

Model Number	BD-B25200LR
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.We confirmed that the gw port was broken at 297 mm from the distal tip.Also, no stretching was observed from the distal tip to the gw port, but about 100 mm of stretching was observed between the gw port and the hub.We have confirmed that the proximal side of the gw port was torn.No nonconformity or abnormality was found in the manufacturing processes according to the device history records (dhr).In addition, actual investigations of the concerned device confirmed the shaft broken, but no cause due to the manufacturing process or design.Neither the dhr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.Factors that may contribute to the shaft broken include, but are not limited to the following.It is probable that the operator delivered the concerned device from the tip of the sheath until the gw port of the product came out.Therefore, when the concerned device was tried to remove from the sheath, the gw used in combination was slackened at the sheath tip and formed a loop.In that state, the operator further pulled the concerned device, so the gw lumen (gw port) of the product was torn in the distal direction by the gw, and the shaft of the product was broken.
Event or Problem Description
Customer was performing a contralateral sfa angioplasty.They had a cook sheath up and over and had the crosperio in the sfa.They had inflated the balloon and had then tried to advance it more distal.Balloon would not advance and they reported that when they tried to then remove the balloon it sheared off of the balloon catheter.They reported they felt resistance upon trying to remove the balloon and had to pull hard to get it out.The balloon was unattached at this point and ended up in the patients profunda.Patient was taken to surgery where balloon was successfully removed.

• 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, osaka 53082 88; JA 5308288
• Manufacturer (Section G): KANEKA CORPORATION OSAKA PLANT; 5-1-1; torikai-nishi; settsu, osaka, osaka 56600 72; JA 5660072
• Manufacturer Contact: joji sengoku ; 1-12-32 akasaka; minato-ku, tokyo 10760-28 ; JA 1076028
• MDR Report Key: 15777264
• Report Number: 3002808904-2022-00014
• Device Sequence Number: 15103463
• Product Code: LIT
• UDI-Device Identifier: 04540778163454
• UDI-Public: 04540778163454
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152887
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/12/2022

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: 08/31/2024
• Device Model Number: BD-B25200LR
• Device Catalogue Number: BD-B25150LR
• Device Lot Number: SR091374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2022
• Initial Report FDA Received Date: 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 88 YR
• Patient Sex: Male