MAUDE Adverse Event Report: TERUMO MEDICAL CORP / KANEKA CORPORATION OSAKA PLANT TERUMO R2P METACROSS RX; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number BD-P30200ER

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/28/2020

Event Type  Injury  

Event Description

Terumo r2-p metacross rx pta balloon dilatation catheter separated and unsheathed leaving the balloon in the aorta/iliac artery during peripheral angiogram; patient required transport to a higher level of care for retrieval.

• Brand Name: TERUMO R2P METACROSS RX
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): TERUMO MEDICAL CORP / KANEKA CORPORATION OSAKA PLANT
• MDR Report Key: 11139290
• MDR Text Key: 226276042
• Report Number: MW5098740
• Device Sequence Number: 1
• Product Code: LIT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: BD-P30200ER
• Device Catalogue Number: BD-P30200ER
• Device Lot Number: SP029238
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 114