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

Model Number	6248V-130
Medical Device Problem Codes	Material Fragmentation (1261); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products - model: dtma1q1, cardiac resynchronization therapy defibrillator (crt-d); implanted: (b)(6) 2019.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during the implant procedure upon slitting the left ventricular delivery catheter the proximal end of the catheter broke off.The distal piece was then held with a hemostat and right angle iris scissors were then used to start a new slit so the remaining catheter could be slit to the distal tip and the entire catheter was removed.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the delivery catheter was returned and analyzed.The mechanical operation of the catheter peeling/slitting/splitting showed a spiral slit.The shaft of the catheter was broken in two pieces at 11 cm.The mechanical operation of the catheter shaft was kinked/buckled.Visual analysis of the catheter indicated damage during use.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ATTAIN SELECT II
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 8789670
• Report Number: 9612164-2019-02856
• Device Sequence Number: 16803970
• Product Code: DQY
• UDI-Device Identifier: 00643169143203
• UDI-Public: 00643169143203
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K123153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2019

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: 04/16/2021
• Device Model Number: 6248V-130
• Device Catalogue Number: 6248V-130
• Device Lot Number: 0009700438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2019
• Initial Date Received by Manufacturer: 06/21/2019
• Supplement Date Received by Manufacturer: 08/01/2019
• Initial Report FDA Received Date: 07/15/2019
• Supplement Report FDA Received Date: 08/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 693565, LEAD / 5076-52, LEAD / 439888, LEAD
• Patient Age: 59 YR
• Patient Weight: 81