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 07/18/2022

Event Type  malfunction  

Event Description

Optiseal peel introducer "wing" broke off when attempting to split the sheath.At this time, the distributor is unable to provide further follow-up information regarding particulates being generated as a result of the event.

Event Description

Optiseal peel introducer "wing" broke off when attempting to split the sheath.At this time, the distributor is unable to provide further follow-up information regarding particulates being generated as a result of the event.

• 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; plymouth MN 55441
• Manufacturer Contact: daniel gil de lamadrid ; 2300 berkshire lane; plymouth, MN 55441
• MDR Report Key: 15262984
• MDR Text Key: 301126882
• Report Number: 2183787-2022-00042
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00821329600579
• UDI-Public: (01)00821329600579(11)211026(17)231026(10)W6563747
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093232
• 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,Followup
• Report Date: 07/25/2022

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: 10/26/2023
• Device Model Number: 1000093-001
• Device Lot Number: W6563747
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/25/2022
• Initial Date FDA Received: 08/20/2022
• Supplement Dates Manufacturer Received: 07/25/2022
• Supplement Dates FDA Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2021
• 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 Outcome(s): Disability
• Patient Age: 73 YR
• Patient Weight: 79 KG