MAUDE Adverse Event Report: GREATBATCH MEDICAL OPTISEAL VALVED PTFE PEELABLE INTRODUCER 6F, 13CM; INTRODUCER, CATHETER

Model Number	1000093-015
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: per on introducer hub and wings broke off.Lot # w6455325.No patient harm or effects on procedure.(b)(6) caller.

• Brand Name: OPTISEAL VALVED PTFE PEELABLE INTRODUCER 6F, 13CM
• Common Device Name: 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: 13057474
• Report Number: 2183787-2021-00113
• Device Sequence Number: 3950987
• Product Code: DYB
• UDI-Device Identifier: 10821329001656
• UDI-Public: (01)10821329001656(11)210811(17)230811(10)W6455235
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: K093232
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/21/2021

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: 08/11/2023
• Device Model Number: 1000093-015
• Device Lot Number: W6455235
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2021
• Initial Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown