MAUDE Adverse Event Report: COOK, INC. MICROPUNCTURE INTRODUCER SET; INTRODUCER, CATHETER

Model Number 4.0 FR OD

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

Patient Problem Foreign Body In Patient (2687)

Event Date 05/29/2021

Event Type  Injury  

Event Description

During a coronary angiogram the micropuncture sheath sheared off with 7.5 cm of sheath left within the patient.The piece was unable to be snared for removal with a snare device.The patient required vascular surgery for removal of the foreign body.Fda safety report id # (b)(4).

• Brand Name: MICROPUNCTURE INTRODUCER SET
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): COOK, INC.
• MDR Report Key: 11946461
• MDR Text Key: 254910400
• Report Number: MW5101726
• 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: 06/03/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: 4.0 FR OD
• Device Catalogue Number: REF# MPIS-402-10.0-SC-NT-U-SST
• Device Lot Number: 13916464
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/04/2021
• 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: 53 YR