MAUDE Adverse Event Report: COOK INCORPORATED MICROPUNCTURE INTRODUCER SET TRANSITIONLESS PUSH-PLUS "STIFFENED CANNULA"; INTRODUCER, CATHETER

Model Number MPIS-501-10.0-NT-SST

Device Problem Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/15/2020

Event Type  Injury  

Event Description

Retained guide wire fragment s/p rhc: ct neck with 9mm wire fragment that appears imbedded in right sternocleidomastoid muscle and the wall of ij without evidence of intraluminal component or associated hematoma.Patient is free of pain and no evidence of secondary infection.Fda safety report id# (b)(4).

• Brand Name: MICROPUNCTURE INTRODUCER SET TRANSITIONLESS PUSH-PLUS "STIFFENED CANNULA"
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INCORPORATED ; bloomington IN 47404
• MDR Report Key: 11064738
• MDR Text Key: 223601384
• Report Number: MW5098491
• Device Sequence Number: 1
• Product Code: DYB
• 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: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MPIS-501-10.0-NT-SST
• Device Catalogue Number: G48007
• Device Lot Number: 13582611
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 55 YR
• Patient Weight: 55