MAUDE Adverse Event Report: GREATBATCH MEDICAL OPTISEAL VALVED PTFE PEELABLE INTRODUCERS 9F; INTRODUCER, CATHETER

Model Number	1000093-004
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: both "wings" of introducer broke off when trying to spilt the sheath.Main body of sheath had to be cut.

• Brand Name: OPTISEAL VALVED PTFE PEELABLE INTRODUCERS 9F
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): GREATBATCH MEDICAL; 2300 berkshire lane; minneapolis MN 55441
• MDR Report Key: 12064828
• Report Number: 2183787-2021-00053
• Device Sequence Number: 19875210
• Product Code: DYB
• UDI-Device Identifier: 10821329600224
• UDI-Public: (01)10821329600224(11)210127(17)230127(10)W6255767
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K093232
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2021

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: 01/27/2023
• Device Model Number: 1000093-004
• Device Lot Number: W6255767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2021
• Initial Date Received by Manufacturer: 06/04/2021
• Supplement Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 06/25/2021
• Supplement Report FDA Received Date: 08/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1