MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INCORPORATED) PERCUTANEOUS CAVITY DRAINAGE CATHETERIZATION; CATHETER, IRRIGATION

Model Number (01)50801902120156

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Pneumothorax (2012)

Event Date 05/20/2021

Event Type  malfunction  

Event Description

Patient had a left percutaneous chest tube placed on (b)(6) 2021 by seldinger's technique.It has been in place since that time functional.Cxr on (b)(6) 2021 noted a worsening pneumothorax, but a wire-density object was noted that did not correlate with a telemetry wire.Ultimately, this chest tube was exchanged for a different tube, and during the exchange a piece of the guidewire was identified at the end of the catheter while it was removed.Fda safety report id # (b)(4).

• Brand Name: PERCUTANEOUS CAVITY DRAINAGE CATHETERIZATION
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INCORPORATED)
• MDR Report Key: 11929586
• MDR Text Key: 254376084
• Report Number: MW5101664
• Device Sequence Number: 1
• Product Code: GBX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: (01)50801902120156
• Device Lot Number: 13F21B0235
• 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 Age: 59 YR