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

Model Number 00884450033005

Device Problems Peeled/Delaminated (1454); Patient Device Interaction Problem (4001); Physical Resistance/Sticking (4012)

Patient Problems Laceration(s) (1946); Myocardial Infarction (1969); Irritability (2421); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)

Event Date 01/07/2023

Event Type  malfunction  

Event Description

Patient presented to the cardiac catheterization lab with signs of a st elevation myocardial infraction (stemi).Patient was found to have a profound clot burden in the mid right coronary artery (rca) through distal distributions.Provider proceeded with intervention."guidewire passed into posterolateral branch.Aspiration atherectomy performed with recovery of thrombus but not significant improvement in flow.Aspiration atherectomy catheter bound to guidewire and all needed to be removed en block.Next shot showed (new) occlusion of the posterior descending artery (pda) at origin.Unable to pass guidewire into the pda.Patient became agitated and pulled right radial sheath.Critical care consulted to intubate patient and left femoral access obtained.Rca accessed with sal 1 guide, wire passed, then posterolateral branch stented, then the rca from just proximal to the pda takeoff to proximal vessel.Still not significant improvement in flow, so segment between distal rca stent and pl stent stented with restoration of normal flow into pl system, but persistent occlusion of pda".When the wire became bound and equipment was removed "en block," it was noted that the teflon coating on the prowater 180cm interventional guidewire had been sheered off of the wire core.The distal aspiration port of the pronto lp extraction catheter appears to be burdened with teflon coating from wire.All prowaters 180cm lot# 220916a15a percutaneous transluminal coronary angioplasty (ptca) catheters were pulled from the shelves in the cath lab.Manufacturer response for wire, guide, catheter, prowater (per site reporter).Asahi intecc co., ltd.Is requesting the product for review.They are completing the paperwork required by the fda with our participation.We have emphasized the need for a quick turn around and they have agreed to move things through the process as fast as they can.

Event Description

Patient presented to the cardiac catheterization lab with signs of a st elevation myocardial infraction (stemi).Patient was found to have a profound clot burden in the mid right coronary artery (rca) through distal distributions.Provider proceeded with intervention."guidewire passed into posterolateral branch.Aspiration atherectomy performed with recovery of thrombus but not significant improvement in flow.Aspiration atherectomy catheter bound to guidewire and all needed to be removed en block.Next shot showed (new) occlusion of the posterior descending artery (pda) at origin.Unable to pass guidewire into the pda.Patient became agitated and pulled right radial sheath.Critical care consulted to intubate patient and left femoral access obtained.Rca accessed with sal 1 guide, wire passed, then posterolateral branch stented, then the rca from just proximal to the pda takeoff to proximal vessel.Still not significant improvement in flow, so segment between distal rca stent and pl stent stented with restoration of normal flow into pl system, but persistent occlusion of pda" when the wire became bound and equipment was removed "en block," it was noted that the teflon coating on the prowater 180cm interventional guidewire had been sheered off of the wire core.The distal aspiration port of the pronto lp extraction catheter appears to be burdened with teflon coating from wire.All prowaters 180cm lot# 220916a15a percutaneous transluminal coronary angioplasty (ptca) catheters were pulled from the shelves in the cath lab.Upon further investigation the prowater guidewire was 100% intact and free of any defect.The teflon noted in the images comes from the inside lumen of the merit medical asap aspirational catheter used during the procedure.There was a single catheter matching the lot number that was pulled from inventory.Further out of an abundance of caution all merit asap extraction catheters were also pulled from inventory.The defect was fully realized by cath lab tech and manager as they manipulated the equipment.Merit medical is going to pick up the item as part of their investigation.

• Brand Name: ASAP®
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 west merit parkway; suite 212; south jordan UT 84095
• MDR Report Key: 16282847
• MDR Text Key: 308650486
• Report Number: 16282847
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 00884450033005
• Device Catalogue Number: ASAP100/B
• Device Lot Number: H2467452
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/19/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/02/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/02/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/03/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27740 DA
• Patient Sex: Female
• Patient Weight: 83 KG