MAUDE Adverse Event Report: ARTHROCARE CORPORATION WEREWOLF FASTSEAL 6.0; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	72290042
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Unspecified Mental, Emotional or Behavioural Problem (4430); Unspecified Gastrointestinal Problem (4491)
Date of Event	08/02/2023
Type of Reportable Event	Death
Event or Problem Description
It was reported that after a surgery for an anterior hip with a fastseal device with no complications, patient consented for participation on (b)(6) 2023 with benign post op course.Starting on the weekend of the (b)(6) 2023, patient was admitted for likely ileus along with reported waxing/waning altered mental status on this day.He quickly decompensated over the following 24-48 hours requiring increase in respiratory support and cv support and ultimately resulted in his death on (b)(6) 2023.The surgical team evaluated the patient with no concerns on the right hip, they considered he was a research patient and deemed that this was a severe adverse event resulting in death of the patient/participant.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Additional Manufacturer Narrative
The information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event based on the additional information received confirming the event was unrelated to the device or its use.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly, and a further report submitted outlining both the event details and our investigations performed.
Event or Problem Description
It was reported that after a surgery for an anterior hip with a fastseal device with no complications, patient consented for participation on (b)(6) 2023 with benign post op course.Starting on the weekend of the (b)(6) 2023, patient was admitted for likely ileus along with reported waxing/waning altered mental status on this day.He quickly decompensated over the following 24-48 hours requiring increase in respiratory support and cv support and ultimately resulted in his death on (b)(6) 2023.The surgical team evaluated the patient with no concerns on the right hip, they considered he was a research patient and deemed that this was a severe adverse event resulting in death of the patient/participant, but was considered unrelated to the study device.

• Brand Name: WEREWOLF FASTSEAL 6.0
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 17611946
• Report Number: 3006524618-2023-00328
• Device Sequence Number: 12449157
• Product Code: GEI
• UDI-Device Identifier: 00885556787229
• UDI-Public: 00885556787229
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K210423
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2023

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?: No
• Device Catalogue Number: 72290042
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2023
• Supplement Date Received by Manufacturer: 09/21/2023
• Initial Report FDA Received Date: 08/24/2023
• Supplement Report FDA Received Date: 09/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown