MAUDE Adverse Event Report: PERFUSION SYSTEMS PENDITURE LAA EXCLUSION SYSTEM; LEFT ATRIAL APPENDAGE CLIP, IMPLANTABLE

Model Number	LAAC50
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that during use of a penditure, it was reported that the clip was migrating and slipping at the base end.The customer removed the clip.The left appendage was left without a clip.They did not end up using another clip on this patient.There was no adverse patient effect associated with this event.Medtronic received additional information that the customer did not use the sizer to confirm the clip size.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Device evaluation summary: visual inspection shows no outward signs of any damage.The clip dimensions were measured to be as follows.Clip length was measured to be 2.00, the specification is 1.98 +/-.04 inches.The jaw teeth height was measured to be 0.021 and 0.021 inches, the specification is 0.020 +/- 0.003 inches.The clamp force was measured to be 2.022 lbs., the specification is 1.9 +/- 0.6 lbs.Reason for return was undetermined.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: PENDITURE LAA EXCLUSION SYSTEM
• Common Device Name: LEFT ATRIAL APPENDAGE CLIP, IMPLANTABLE
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 19836810
• Report Number: 2184009-2024-00437
• Device Sequence Number: 17862285
• Product Code: PZX
• UDI-Device Identifier: 00763000791476
• UDI-Public: 00763000791476
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K232295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 10/14/2024

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: 01/25/2025
• Device Model Number: LAAC50
• Device Catalogue Number: LAAC50
• Device Lot Number: T4A183X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 10/14/2024
• Date Device Manufactured: 01/25/2024
• 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
• Patient Sex: Unknown