MAUDE Adverse Event Report: ABBOTT VASCULAR PROSTAR XL SUTURE-MEDIATED CLOSURE; VESSEL CLOSURE SUTURE

Model Number	12322-01
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this was a vessel closure of an unknown vessel using a prostar xl after an unknown procedure.Reportedly, the device broke or malfunctioned.An unknown method was used to achieve hemostasis.There was no adverse patient sequela and no reported clinically significant delay in the procedure or therapy.No additional information was provided.
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
Analysis was performed on the returned suture.The reported unspecified failure mode could not be verified because the device was returned in the pre-deployed position.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Similarity could not be determined as a specific failure mode was not provided and a failure mode could not be identified based on the returned device condition.Based on the returned device condition and the information available, a conclusive cause could not be determined.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.B1 - adverse event/product problem: adverse event removed b2 - outcomes attributed to ae: required intervention changed to na.B5: describe event or problem - updated.H1 - type of reportable event changed from serious injury to malfunction.H6: health effect impact code - 4641 removed.
Event or Problem Description
It was reported that this was a vessel closure of an unknown vessel using a prostar xl after an unknown procedure.Reportedly, the device broke or malfunctioned.An unknown method was used to achieve hemostasis.There was no adverse patient sequela and no reported clinically significant delay in the procedure or therapy.No additional information was provided.Subsequent to previously filed report, the returned device analysis noted the device was returned in the pre-deployed condition.A lumen was missing and not returned for one of the suture ends.There was no blood in or on the device, i.E., no patient involvement.

• Brand Name: PROSTAR XL SUTURE-MEDIATED CLOSURE
• Common Device Name: VESSEL CLOSURE SUTURE
• 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: 15711569
• Report Number: 2024168-2022-11156
• Device Sequence Number: 6584095
• Product Code: MGB
• UDI-Device Identifier: 08717648000621
• UDI-Public: 08717648000621
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P960043
• 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): 11/18/2022

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: 10/31/2023
• Device Model Number: 12322-01
• Device Catalogue Number: 12322-01
• Device Lot Number: 1122241
• 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: 10/11/2022
• Supplement Date Received by Manufacturer: 11/16/2022
• Initial Report FDA Received Date: 11/01/2022
• Supplement Report FDA Received Date: 11/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2021
• 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
• Patient Sex: Unknown