MAUDE Adverse Event Report: TERUMO MEDICAL CORP. R2P DESTINATION SLENDER GUIDING SHEATH; INTRODUCER, CATHETER

Model Number BD-P600Y0ER

Device Problems Difficult to Remove (1528); Material Rupture (1546)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 11/05/2019

Event Type  Injury  

Event Description

The 6mm x 40mm balloon ruptured in the left iliac when trying to remove the balloon it was hung up on sheath and had to be removed as one unit.At the access site they had to make the site big with a scalpel.A tr band was placed on site after the device was removed.Terumo-fr 6 destination slender guiding sheath - gs-r6st1c12w terumo r2p matacross rx pta balloon dilatation catheter - bd-p60040er.Fda safety report id# (b)(4).

• Brand Name: R2P DESTINATION SLENDER GUIDING SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORP. ; elkton MD 21921
• MDR Report Key: 9653533
• MDR Text Key: 177389700
• Report Number: MW5092652
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• 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: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BD-P600Y0ER
• Device Catalogue Number: GS-R6ST1C12W
• 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): Required Intervention
• Patient Age: 47 YR
• Patient Weight: 86