MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. ASAP ASPIRATION CATHETER

Catalog Number ASAP100/B

Device Problems Failure to Deliver (2338); Compatibility Problem (2960)

Patient Problem Myocardial Infarction (1969)

Event Date 04/23/2019

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 an emergent thrombectomy procedure, the physician could not manipulate the thromoaspiration catheter.The physician had acquired retrograde arterial access and had quickly introduced a coronary guidewire and guide catheter into the patient's cardiovascular system.During the procedure the physician could not manipulate the aspiration catheter to the desired targeted anatomy.The physician had no choice but to remove the interventional equipment from the patient's vasculature and provide an alternate method of reperfusion.The physician states that an emergent thrombectomy and angioplasty on a patient with st elevation, myocardial infarction [stemi] is a lifesaving procedure.No patient injury to report.

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: ASAP ASPIRATION CATHETER
• Type of Device: ASPIRATION CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan, UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan, UT 84095
• Manufacturer Contact: katie swenson cqe,cba,cqpa. ; 1600 merit parkway; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 8660087
• MDR Text Key: 146790150
• Report Number: 1721504-2019-00037
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K100569
• 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: 04/24/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: ASAP100/B
• Device Lot Number: H1330850
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/23/2019
• Initial Date FDA Received: 05/31/2019
• Supplement Dates Manufacturer Received: 07/02/2019
• Supplement Dates FDA Received: 07/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2018
• 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): Life Threatening