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 Material Separation (1562); Material Integrity Problem (2978)

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

Event Date 06/29/2022

Event Type  malfunction  

Event Description

Hi, i wanted to report a product event that occurred to me.I'm calling in regards to an optiseal sealable introducer that broke.It is regarding the 6-french 13 cm model: 1000093-001.This occurred on implant date of (b)(6) 2022.The patient, everything went as planned with the entirety of the case.The only issue was when the physician went to break the hub on the introducer, half of the hub broke off and went into the patient pocket that was not seen by the physician, but by the scrub tech.The piece of hub was taken out of the pocket and extracted from the body.There were no issues, no patient issues with the case.The patient went home the following day.Weight of the patient was not recorded.

• 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 north; minneapolis MN 55441
• Manufacturer Contact: samuel master ; 2300 berkshire lane north; minneapolis, MN 55441 ; 7639518115
• MDR Report Key: 15136602
• MDR Text Key: 304716647
• Report Number: 2183787-2022-00040
• Device Sequence Number: 1
• Product Code: DYB
• 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: 07/29/2022

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 Model Number: 1000093-001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/04/2022
• Initial Date FDA Received: 07/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 52 YR
• Patient Sex: Female