MAUDE Adverse Event Report: ARGON MEDICAL DEVICES ATRIEVE VASCULAR SNARE KIT 3.2FR

Model Number	381003004
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned, and evaluation is anticipated but it has not yet begun.A photo was received as well.A follow-up report will be submitted once the device has been evaluated.
Event or Problem Description
Detachment of the platinum maker loop was reported.Details: the atireve was used to remove a guide wire left in lmt at pci procedure.The doctor tried to remove the guide wire by atrieve with a 6f guiding catheter several times.Then after the atrieve and the delivery catheter was taken out from the 6f guiding catheter and when another medical device was inserted to the guiding catheter, it stuck in the catheter.The guiding catheter was checked under x-ray, and a black object was confirmed in the catheter.The guiding catheter was removed from the patient and found that the object stuck in the catheter was the platinum marker loop of the atrieve delivery catheter.The platinum loop was removed from the guiding catheter then the procedure was carried on and completed.The detached platinum loop was not returned only the snare and the delivery catheter was returned, however, a photo was provided.The customer wants to know the root cause of the detachment of the loop.
Additional Manufacturer Narrative
One opened delivery catheter sheath and one atrieve device was returned for review.A visual and functional inspection was performed on the returned products.The inspection established that the delivery catheter sheath was kinked and had a couple small holes by the hub.The platinum at the end of the loops were found to be broken.The atrieve was put inside the catheter and no resistance was felt during the functional test.A definite root cause for the damage cannot be determined.One possibility that would explain the kink near the hub and would cause the platinum to break is the application of excessive force during manipulation of the device.The ifu warns the user with the following: pull forces applied to catheters during fibrin sheath stripping may damage, stretch, or break indwelling catheters 6 french or smaller in diameter.Do not use excessive pull force when attempting fibrin sheath stripping of catheters 6 french or smaller in diameter.Do not use excessive force when manipulating the catheter through an introducer.Excessive force may damage the catheter.
Event or Problem Description
Detachment of the platinum maker loop was reported.Details: the atireve was used to remove a guide wire left in lmt at pci procedure.The doctor tried to remove the guide wire by atrieve with a 6f guiding catheter several times.Then after the atrieve and the delivery catheter was taken out from the 6f guiding catheter and when another medical device was inserted to the guiding catheter, it stuck in the catheter.The guiding catheter was checked under x-ray, and a black object was confirmed in the catheter.The guiding catheter was removed from the patient and found that the object stuck in the catheter was the platinum marker loop of the atrieve delivery catheter.The platinum loop was removed from the guiding catheter then the procedure was carried on and completed.The detached platinum loop was not returned only the snare and the delivery catheter was returned, however, a photo was provided.The customer wants to know the root cause of the detachment of the loop.Additional information: the complaint lot number was purchased by cosmotec from argon directly.

• Brand Name: ATRIEVE VASCULAR SNARE KIT 3.2FR
• Common Device Name: ATRIEVE VASCULAR SNARE
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• MDR Report Key: 12603198
• Report Number: 0001625425-2021-01092
• Device Sequence Number: 4212067
• Product Code: MMX
• UDI-Device Identifier: 20886333003970
• UDI-Public: 20886333003970
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K021606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/19/2023
• Device Model Number: 381003004
• Device Catalogue Number: 381003004
• Device Lot Number: 11211429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/14/2021
• Supplement Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 10/11/2021
• Supplement Report FDA Received Date: 10/22/2021
• 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: Other