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

Model Number	1000093-015
Medical Device Problem Codes	Material Separation (1562); Use of Device Problem (1670); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/16/2018
Type of Reportable Event	Malfunction
Event or Problem Description
As reported the sheath split into 3 pieces and required that the distal end to be removed with a hemp stat.

• 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
• MDR Report Key: 7936092
• Report Number: 2183787-2018-00076
• Device Sequence Number: 13688294
• Product Code: DYB
• UDI-Device Identifier: 00821329600579
• UDI-Public: 00821329600579
• 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
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/05/2018

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: 06/11/2020
• Device Model Number: 1000093-015
• Device Lot Number: W4304189
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1