MAUDE Adverse Event Report: TELEFLEX MEDICAL TELEFLEX VSL MICRO-INTRODUCER KIT 5FR; INTRODUCER, CATHETER

Catalog Number 7256V

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/19/2019

Event Type  Injury  

Event Description

When inserting micro puncture sheath and the cardiologist attempted to insert wire after removal of dilator and when the wire would not go, he attempted to remove introducer and the hub snapped off and the catheter was below the skin level and the distal end was in the left femoral artery.Another provider was consulted and together they retried the catheter using a snare.They attempted to go from the right radial and was successful from the left femoral.The rest of the catheterization and the ptca proceeded without difficulty.The equipment was: vsi micro-introducer kit 5fr.Ref 7256v, lot # 252619, expiration 2022-05-31.Fda safety report id # (b)(4).

• Brand Name: TELEFLEX VSL MICRO-INTRODUCER KIT 5FR
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TELEFLEX MEDICAL
• MDR Report Key: 9117093
• MDR Text Key: 160068777
• Report Number: MW5090001
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 7256V
• Device Lot Number: 652619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2019
• 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): Required Intervention
• Patient Age: 79 YR