MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. IMPRESS PERIPHERAL CATHETER

Catalog Number 412535HH1

Device Problems Fracture (1260); Material Separation (1562)

Patient Problems Ischemia (1942); Vascular System (Circulation), Impaired (2572); Foreign Body In Patient (2687)

Event Date 05/22/2019

Event Type  Injury  

Manufacturer Narrative

The device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The account alleges that during a peripheral artery angioplasty procedure, the catheter tip detached within the patient.The physician had acquired retrograde femoral artery access and had negotiated the patient's common iliac bifurcation with a guidewire and a 4f, 125cm catheter.During catheter manipulations and below the patient's knee [btk] over an.014 interventional guidewire, the catheter tip detached.The account alleges that the patient's vasculature was not severely calcified or tortuous.The physician was unsuccessful in retrieving the foreign object from the patient's periphery using a vascular snare device.The patient was then sent to surgery for an additional attempt to remove the foreign body.The surgical attempt was unsuccessful in removing the foreign body from the patient's leg.The account alleges that as a result of two failed attempts, to remove the foreign body from the patient, the patient's leg was amputated below the knee.The patient tolerated the procedure well.

Manufacturer Narrative

The suspect device was not returned for evaluation.The complaint could not be confirmed and a root cause could not be determined.A review of the device history record was performed and no exception documents were found.A review of the complaint database was performed and no similar complaints for this lot number were found.

• Brand Name: IMPRESS PERIPHERAL CATHETER
• Type of Device: PERIPHERAL CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 14646 kirby drive; houston TX 77047
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; 14646 kirby drive; houston TX 77047
• Manufacturer Contact: katie swenson cqe,cba,cqpa. ; 1600 merit parkway; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 8680353
• MDR Text Key: 147380853
• Report Number: 3010665433-2019-00039
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K0513171
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 412535HH1
• Device Lot Number: E967193
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability