MAUDE Adverse Event Report: ABBOTT VASCULAR STARCLOSE SE VASCULAR CLOSURE SYSTEM; VESSEL CLOSURE CLIP

Catalog Number	14679-05
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that this was an arteriotomy closure of a right common femoral artery using a starclose se after a diagnostic cerebral angiogram procedure with a 6f sheath.Reportedly, there was resistance advancing the thumb advancer due to the sheath not splitting properly.The sheath failed to split.Prolonged manual compression was used to achieve hemostasis.Post recovery hospitalization was prolonged.No additional information was provided.
Additional Manufacturer Narrative
H6: medical device problem code 2017 - failure to follow steps.Analysis was performed on the returned device.The reported resistance advancing the thumb advancer due to the sheath not splitting properly was confirmed based on the returned device condition.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents from this lot.It should be noted that the starclose instructions for use (ifu), closure procedure section, states: if excessive resistance is experienced during advancement of the thumb advancer, manually collapse the locator wings.Slide the safety release on the device to collapse the locator wings.In this case, the device was returned with the plunger disengaged, and vessel locator wings collapsed indicating the safety release was used to remove the device.Additional information was asked if the safety release was used, and the response indicated ¿no¿.It may be possible that they meant the access ports which is another type of safety release function on the device.The observed evidence of damage to the flex-guide (carving) and garage leaves indicates there was device angle change during thumb advancer/slider stroke such that the garage leaves interacted with the flex-guide and sheath.Interaction with these internal components subsequently contributed to the reported failure to split the sheath.The subsequent treatment appears to be related to procedure circumstance.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
Event or Problem Description
It was reported that this was an arteriotomy closure of a right common femoral artery using a starclose se after a diagnostic cerebral angiogram procedure with a 6f sheath.Reportedly, there was resistance advancing the thumb advancer due to the sheath not splitting properly.The sheath failed to split.Prolonged manual compression was used to achieve hemostasis.Post recovery hospitalization was prolonged.No additional information was provided.Subsequent to the previously filed report, the following information was received: reportedly, the safety release button was not used prior to removing the device.There was a reported clinically significant delay.No additional information was provided.

• Brand Name: STARCLOSE SE VASCULAR CLOSURE SYSTEM
• Common Device Name: VESSEL CLOSURE CLIP
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 18465268
• Report Number: 2024168-2024-00301
• Device Sequence Number: 17912115
• Product Code: MGB
• UDI-Device Identifier: 08717648175060
• UDI-Public: 08717648175060
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P050007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2024

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: 03/01/2025
• Device Catalogue Number: 14679-05
• Device Lot Number: 3063041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2023
• Supplement Date Received by Manufacturer: 03/18/2024
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Unknown
• Patient Weight: 106 KG