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

Model Number	6248V-130P
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product event summary: the delivery catheter was returned and analyzed.The analysis indicated that the catheter did not peel along the score lines.The mechanical operation of the catheter was damaged.There was an issue with the catheter shaft.The mechanical operation of the catheter shaft was kinked/buckled.The mechanical operation of the catheter peeling/slitting/splitting showed a spiral slit.Visual analysis of the delivery catheter indicated damage during use.The analyst noted a partial delivery catheter was returned.The distal end of the delivery catheter was broken at 42.3 cm.The shaft of the delivery catheter was kinked at 32 cm.The shaft of the delivery catheter was spiral slit.Slitting on the hub of the delivery catheter was not on the score line.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the physician had extreme difficulty slitting the delivery catheter, more specifically getting the slitter to move through the hub of the catheter.The hub appeared to be out of alignment.Eventually the slitter did work through the hub but a tremendous amount of force had to be applied.No patient complications have been reported as a result of this event.

• Brand Name: ATTAIN SELECT II
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 9558141
• Report Number: 9612164-2020-00117
• Device Sequence Number: 2408659
• Product Code: DQY
• UDI-Device Identifier: 00643169184183
• UDI-Public: 00643169184183
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K123153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2020

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: 08/22/2021
• Device Model Number: 6248V-130P
• Device Catalogue Number: 6248V-130P
• Device Lot Number: 0009886587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2019
• Initial Date Received by Manufacturer: 12/16/2019
• Supplement Date Received by Manufacturer: 01/08/2020
• Initial Report FDA Received Date: 01/07/2020
• Supplement Report FDA Received Date: 01/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR