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

Model Number	00884450329306
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem 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.
Additional 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
• Common Device Name: ASPIRATION CATHETER,
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan, ut
• MDR Report Key: 9920874
• Report Number: 1721504-2020-00023
• Device Sequence Number: 19671645
• Product Code: DXE
• UDI-Device Identifier: 00884450329306
• UDI-Public: 00884450329306
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 03/04/2020
• Supplement Date Received by Manufacturer: 03/04/2020
• Initial Report FDA Received Date: 04/03/2020
• Supplement Report FDA Received Date: 06/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention