MAUDE Adverse Event Report: ABBOTT VASCULAR FEMOSTOP II PLUS; CLAMP, VASCULAR

Catalog Number UNK FEMOSTOP II PLUS

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Hematoma (1884); Nerve Damage (1979); Pain (1994); Swelling/ Edema (4577)

Event Date 11/18/2020

Event Type  Injury  

Event Description

It was reported that after a cardiac catheterization procedure done on (b)(6) 2020, manual compression was applied to the right groin to achieve hemostasis.About 5 hours after the procedure, a knot/lump was noted in the groin and some bleeding was noted.A femostop device was placed at about 6:00 pm.The whole night the patient experienced tightness and was unable to get up to use the bathroom.By 8:00 am, the femostop device had been on the patient for 14 hours without it being monitored.Per the physician¿s orders, the femostop was removed as there was no bleeding.The patient had severe bruising and swelling all around the groin.He could not feel the sensation or urge to urinate, and he had to be catheterized.An ultrasound was done on the bladder.On (b)(6) 2020, the patient was unable to urinate, and the groin area was black.The patient returned to hospital and was sent to the emergency room to get catheterized.Now two years later, the patient has had urinary problems (no control of bladder) and numbness all the way down right leg.No additional information was provided.

Manufacturer Narrative

D4- the udi number is not known as the catalogue number was not provided.H6- device code 2017/failure to follow steps / instructions.Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Manufacturer Narrative

The device was not returned for evaluation.A review of the lot history record and complaint history of the reported device could not be conducted because the part and lot number were not provided.Reportedly, the femostop device had been on the patient for 14 hours without it being monitored.It should be noted that the warning in the femostop ii plus instructions for use (ifu) states: do not leave the system on the patient for inappropriately long compressions, as tissue damage may occur.A brief interruption at least every three hours of pressure is recommended during long compression periods.Inappropriately long compression and/or immobilization may increase the risk for thrombosis or embolization which could lead to patient injury or death.In this case it is possible the ifu deviation contributed to the reported patient effects.The investigation determined the reported ifu violation was due to operator error and the patient effects and treatment appear to be related to circumstances of the procedure.The reported patient effects of pain and hematoma are listed in the femostop ii plus ifu as known adverse events associated with use of suture mediated closure devices.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.B1: adverse event/product problem - product problem removed.B2: outcomes attributed to ae - disability or permanent damage added.

• Brand Name: FEMOSTOP II PLUS
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT MEDICAL REG#3009600098; 4 robbins rd; westford MA 01886
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 16887794
• MDR Text Key: 314757437
• Report Number: 2024168-2023-04877
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982182
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK FEMOSTOP II PLUS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention; Disability; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 100 KG