MAUDE Adverse Event Report: ARGON MEDICAL DEVICES, INC. MIS-7F07] 7F MICRO INTRODUCER SET

Catalog Number MIS-7F07

Device Problems Material Fragmentation (1261); Material Frayed (1262)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/11/2016

Event Type  Injury  

Manufacturer Narrative

The device history record could not be reviewed because the lot number was not provided.The complaint sample was not returned for evaluation even though the complainant stated that a sample would be returned.If the sample is returned, it will be evaluated and the report will be updated.The (b)(4) introducer set uses a (b)(4) mandrel wire.From the event statement, it was noted that the doctor encountered some sort of resistance and pulled with more additional force than normal.The wire frayed and a piece broke off inside the patient.The ifu states warning withdrawal, pullback, or manipulation of the guidewire when resistance is met may cause guidewire damage, breakage, or embolization.In precautions at no time should the introducer or guidewire be advanced or withdrawn when resistance is met without determining the cause by fluoroscopic examination or suitable imaging method.It is probable that inadvertently using more than normal force during the resistance encountered caused the breakage of the wire.

Event Description

When attempting to remove the wire dr.(b)(6) encountered resistance.He pulled with additional force than normal, the wire frayed and a piece broke off inside the patient.The piece of wire was left in the patient and now the patient wants it surgically removed.Dr.(b)(6) is scheduled to remove the wire next week.

• Brand Name: MIS-7F07] 7F MICRO INTRODUCER SET
• Type of Device: MICRO INTRODUCER SET
• Manufacturer (Section D): ARGON MEDICAL DEVICES, INC.; 1445 flat creek road; athens TX 75007
• Manufacturer (Section G): ARGON MEDICAL DEVICES, INC.
• Manufacturer Contact: gail smith ; 1445 flat creek road; athens, TX 75007 ; 2144368995
• MDR Report Key: 5505344
• MDR Text Key: 40532098
• Report Number: 1625425-2015-00092
• Device Sequence Number: 1
• Product Code: DRE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K780126
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/16/2016

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 Catalogue Number: MIS-7F07
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/18/2016
• Initial Date FDA Received: 03/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention