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

Model Number 00884450329306

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

Patient Problem Foreign Body In Patient (2687)

Event Date 03/04/2020

Event Type  malfunction  

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 a percutaneous transluminal coronary intervention [stemi] procedure, the tip of an aspiration catheter [rx lumen] detached within the patient's distal right coronary artery [rca].The physician had acquired retrograde arterial access and had negotiated the aortic arch to successful cannulate and opacify the patients ostial rca.The physician ballooned the rca vessel and then inserted the aspiration catheter into the posterior descending artery [culprit lesion] of the distal rca.[this was appreciated from the rpo angle] the aspiration catheter became stuck at the distal rca bifurcation.The physician stated that the vessel had spasm.The physician attempted to administer nitro and verapamil with no success.A vascular snare devise was unsuccessfully used to retrieve the detached tip.An interventional pci balloon was inserted next to the detached tip to attempt to dislodge the catheter tip with no success.Eventually the patients rca was completely stented, and the aspiration catheter tip was jailed within the tunica intima of the rca with no additional consequences to the patient.The patient was transferred to icu for continuous observation.

Manufacturer Narrative

The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.

• Brand Name: ASAP ASPIRATION CATHETER
• Type of Device: ASPIRATION CATHETER,
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan, ut
• MDR Report Key: 9920874
• MDR Text Key: 186548273
• Report Number: 1721504-2020-00023
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00884450329306
• UDI-Public: 00884450329306
• Combination Product (y/n): N
• PMA/PMN Number: K132155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/04/2020

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: 11/22/2022
• Device Model Number: 00884450329306
• Device Catalogue Number: ASAPLP/C
• Device Lot Number: H1731072
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/04/2020
• Initial Date FDA Received: 04/03/2020
• Supplement Dates Manufacturer Received: 03/04/2020
• Supplement Dates FDA Received: 06/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention