MAUDE Adverse Event Report: MEDTRONIC IRELAND ATTAIN SELECT II; CATHETER, PERCUTANEOUS

Model Number	6248V-130
Medical Device Problem Codes	Accessory Incompatible (1004); Break (1069); Mechanical Problem (1384); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that during the implant procedure, a few different catheters were used as there was slitting difficulty that caused the left ventricular (lv) lead to dislodge.It was noted that the catheters kept breaking and that the valves were very difficult to pass through.One of the catheters became stuck in the valve during the lead implant.A different lv lead was successfully implanted.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Corrected: b7.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
Product event summary: the delivery catheter was returned and analyzed.The shaft of the delivery catheter was spiral slit.The catheter shaft was torn.The shaft on the hub of the delivery catheter was spiral slit.Visual analysis of the delivery catheter indicated damage during use.The analyst noted the delivery catheter was returned in two pieces.The slitter was not returned.Slitting had started and terminated two times on the hub of the delivery catheter.Slitting did not start on the centerline of the hub of the delivery catheter.The hub of the delivery catheter was spiral slit.The shaft of the delivery catheter was spiral slit.There were chatter marks on the shaft of the delivery catheter during slitting.The shaft of the delivery catheter was torn at 41 cm.Slitting had terminated and restarted at 47 cm.The shaft of the delivery catheter was torn apart at 55 cm.Lead insertion was not able to be performed as the hemostasis valve was already slit and the valve tool was not returned.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: ATTAIN SELECT II
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 7635269277
• MDR Report Key: 22144210
• Report Number: 9612164-2025-02740
• Device Sequence Number: 18014103
• Product Code: DQY
• UDI-Device Identifier: 00763000160517
• UDI-Public: 00763000160517
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K123153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/11/2025

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: 08/13/2026
• Device Model Number: 6248V-130
• Device Catalogue Number: 6248V-130
• Device Lot Number: 0012395897
• 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: 05/14/2025
• Supplement Date Received by Manufacturer: 06/04/2025; 06/09/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 06/04/2025; 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2024
• 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 Age: 58 YR
• Patient Sex: Male