MAUDE Adverse Event Report: GREATBATCH MEDICAL OPTISEAL VALVED PTFE PEELABLE INTRODUCER SP KIT, 5 PACK, 6FR, 13CM; INTRODUCER, CATHETER

Model Number 1000093-001

Device Problems Fracture (1260); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/08/2022

Event Type  malfunction  

Event Description

During a routine pacemaker implant the physician was using an abbott approved and abbott supplied introducer sheath that failed it was made by greatbatch medical.The sheaths tab handle sheared off of the side of the hub while the physician was trying to peel it away from the lead.He then needed to crudely grasp the side of the hub with a hemostat clamp to detach the lead thus risking the insulation and the lead itself.These sheaths were newly approved as the exclusive introducer sheath to be used by the crm division.We can no longer order the merit medical brand that we've used successfully for years.

• Brand Name: OPTISEAL VALVED PTFE PEELABLE INTRODUCER SP KIT, 5 PACK, 6FR, 13CM
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): GREATBATCH MEDICAL; 2300 berkshire lane north; minneapolis MN 55441
• Manufacturer Contact: samuel master ; 2300 berkshire lane; minneapolis, MN 55441 ; 7639518115
• MDR Report Key: 14167583
• MDR Text Key: 289779882
• Report Number: 2183787-2022-00022
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00821329600579
• UDI-Public: (01)00821329600579(11)210415(17/0230415(10)W6374408
• 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: 04/20/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 04/15/2023
• Device Model Number: 1000093-001
• Device Lot Number: W6374408
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/24/2022
• Initial Date FDA Received: 04/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2021
• 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: 77 YR
• Patient Sex: Male
• Patient Weight: 79 KG