MAUDE Adverse Event Report: KANEKA CORPORATION R2P METACROSS RX PTA BALLOON DILATATION CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL,,

Catalog Number BD-P50200ER

Device Problems Use of Device Problem (1670); Device Handling Problem (3265)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/26/2019

Event Type  Injury  

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.Probable cause(s) and our comment: we speculate the reported situation as follows: because it is used in calcified lesions, the rupture occurred because the balloon was damaged at the hard part of the lesion.Further, the operation was not possible at the lesioned part or the tip of the combined device (for example, gc), and when the catheter was removed from the stucked state, the balloon was broken by an excessive tensile force.This was considered a malfunction caused by the procedure.

Event Description

The account was attempting to pta a heavily calcified sfa when the balloon would not advance forward or could it be removed over the wire before it fractured.An open surgical foreign body retrieval was performed to remove the balloon.The balloon was removed.The patient is stable and recovering.

• Brand Name: R2P METACROSS RX PTA BALLOON DILATATION CATHETER
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL,,
• Manufacturer (Section D): KANEKA CORPORATION; 2-3-18; nakanoshima,kita-ku; osaka, osaka 53082 88; JA 5308288
• Manufacturer Contact: kitamura yoshiyuki ; 2-3-18; nakanoshima,kita-ku; osaka, osaka 53082-88 ; JA 5308288
• MDR Report Key: 9231315
• MDR Text Key: 166795854
• Report Number: 3002808904-2019-00029
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 04540778167117
• UDI-Public: 04540778167117
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163479
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: BD-P50200ER
• Device Lot Number: SP049083
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR