MAUDE Adverse Event Report: COOK INCORPORATED MICROPUNCTURE; INTRODUCER, CATHETER

Catalog Number G48002

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/17/2019

Event Type  malfunction  

Event Description

Upon gaining access into the vessel, the wire from the micropuncture set became stuck within the patient's fistula when they attempted to remove the inner introducer.This was not known until we attempted to remove the wire.There was tension and then the distal portion of the wire broke away and remained in the patient.The provider stopped the procedure.The patient is being treated for foreign body removal of the remaining wire.

• Brand Name: MICROPUNCTURE
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INCORPORATED; 6300 n. matthews dr.; ellettsville IN 47429
• MDR Report Key: 8831653
• MDR Text Key: 152373055
• Report Number: 8831653
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: G48002
• Device Lot Number: 9463087
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/18/2019
• Event Location: Hospital
• Date Report to Manufacturer: 07/26/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22995 DA