MAUDE Adverse Event Report: GREATBATCH MEDICAL OPTISEAL VALVED PTFE PEELABLE INTRODUCER 8F; INTRODUCER, CATHETER

Model Number 1000093-003

Device Problems Material Deformation (2976); Material Integrity Problem (2978); Material Twisted/Bent (2981)

Patient Problems Arrhythmia (1721); Tachycardia (2095)

Event Date 03/11/2022

Event Type  Injury  

Event Description

Dr (b)(6) used peelable introducers model number 1000093-001 and 1000093-03 for a dual chamber icd placement.Dr (b)(6) placed both introducers into the blood vessel.He then began placing rv icd lead via model 1000093-03.While manipulating icd lead the introducer consistently kinked at the hub of where the peelable portion of the introducer met the wings where you peel.He had to manipulate the introducer while trying to position the lead.At one point he was unable to quickly maneuver the lead and pt had sustained vt which required an external defibrillation.He did state he should have maneuvered lead better to prevent vt, but said the introducer did make it more difficult.

• Brand Name: OPTISEAL VALVED PTFE PEELABLE INTRODUCER 8F
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): GREATBATCH MEDICAL; 2300 berkshire lane; minneapolis MN 55441
• Manufacturer Contact: samuel master ; 2300 berkshire lane; minneapolis, MN 55441 ; 7639518115
• MDR Report Key: 14167591
• MDR Text Key: 289750929
• Report Number: 2183787-2022-00023
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063182
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1000093-003
• Device Catalogue Number: 1000093-003
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Life Threatening
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 127 KG