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 Fragmentation (1261)

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

Event Date 08/02/2021

Event Type  malfunction  

Event Description

Wing broke off and unable to split sheath as per normal.Used hemostat to grab edge of sheath and split using wing that was still attached.

• 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; minneapolis MN 55441
• Manufacturer Contact: samuel master ; 2300 berkshire lane; minneapolis, MN 55441 ; 7639518115
• MDR Report Key: 12579993
• MDR Text Key: 274990410
• Report Number: 2183787-2021-00085
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 0082132900579
• UDI-Public: (01)0082132900579(11)210519(17)230519(10)W6235329
• 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: 10/05/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2023
• Device Model Number: 1000093-001
• Device Catalogue Number: N/A
• Device Lot Number: W6235329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2021
• Initial Date Manufacturer Received: 09/08/2021
• Initial Date FDA Received: 10/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2021
• 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