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

Model Number 6248V-90S

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/31/2019

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during the implant procedure, the physician was attempting to place the left ventricular (lv) lead when the catheter was unable to be advanced due to patient anatomy.The physician attempted to slit the inner catheter but was not able to slit all the way through the white hub.The tip of the catheter broke off.No lv lead was implanted.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the delivery catheter was returned and analyzed.Analysis indicated the mechanical operation of the catheter slitting showed a spiral slit.The mechanical operation of the catheter shaft was kinked.The catheter did not slit along the score lines.Visual analysis of the lead indicated damage during use.The analyst noted that visual inspection found slitting was not straight on score line caused spiral slit.Spiral slitting led to the catheter being broken into two pieces.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ATTAIN SELECT II
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9341897
• MDR Text Key: 170791609
• Report Number: 9612164-2019-04806
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00643169143197
• UDI-Public: 00643169143197
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/05/2021
• Device Model Number: 6248V-90S
• Device Catalogue Number: 6248V-90S
• Device Lot Number: 0009909034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 76 YR