MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC PERFORMA DIAGNOSTIC CATHETER

Catalog Number 7718-A0/B

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

Patient Problems Aneurysm (1708); Low Blood Pressure/ Hypotension (1914)

Event Date 06/19/2017

Event Type  Injury  

Manufacturer Narrative

The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The account alleges that during an endovascular aortic aneurism repair [evar] the catheter tip detached within the patients lower abdomen.The physician had acquired bilateral femoral retrograde access with two 6f sheaths.During guide catheter manipulations over a stiff.038 guidewire the catheter tip detached in the patient's descending aorta and migrated to the patient's common iliac artery.The physician then used a vascular snare device to successfully retrieve the catheter tip from the patient.The patient tolerated the procedure well.

Manufacturer Narrative

The suspect device was not returned for evaluation.The complaint could not be confirmed and the root cause could not be determined.Several unused units from the same lot were returned and inspected.No defects were found.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.Corrective actions are in process.

• Brand Name: PERFORMA DIAGNOSTIC CATHETER
• Type of Device: DIAGNOSTIC CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC; 1600 west merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC; 8830 siempre viva rd #100; san diego CA 92154
• Manufacturer Contact: casey hughes, ms, cqe, csqp ; 1600 west merit parkway; south jordan, UT 84095
• MDR Report Key: 6675612
• MDR Text Key: 78651694
• Report Number: 3011642792-2017-00009
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K943739
• 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: 06/19/2017

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 Expiration Date: 11/30/2018
• Device Catalogue Number: 7718-A0/B
• Device Lot Number: I877300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/19/2017
• Initial Date FDA Received: 06/28/2017
• Supplement Dates Manufacturer Received: 08/28/2017
• Supplement Dates FDA Received: 09/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2016
• 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): Required Intervention