MAUDE Adverse Event Report: ARROW TELEFLEX BALLOON WEDGE PRESSURE CATHETER SWAN GANZ CATHETER; CATHETER FLOWDIRECTED

Catalog Number A1-07124

Device Problems Deflation Problem (1149); Component Missing (2306); Device Dislodged or Dislocated (2923)

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

Event Date 09/30/2019

Event Type  Injury  

Event Description

During cardiac catheterization, swan ganz catheter balloon would not deflate and became dislodged from the catheter.Balloon not found.Fda safety report id# (b)(4).

• Brand Name: BALLOON WEDGE PRESSURE CATHETER SWAN GANZ CATHETER
• Type of Device: CATHETER FLOWDIRECTED
• Manufacturer (Section D): ARROW TELEFLEX; morrisville NC 27560
• MDR Report Key: 9156281
• MDR Text Key: 161400877
• Report Number: MW5090207
• Device Sequence Number: 1
• Product Code: DYG
• 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: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: A1-07124
• Device Lot Number: 16F1960032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• 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): Other
• Patient Age: 54 YR
• Patient Weight: 74