MAUDE Adverse Event Report: GREATBATCH MEDICAL OPTISEAL NSP BULK NON-STERILE, 8FR, 13CM; INTRODUCER, CATHETER

Model Number 1002636-003

Device Problems Loss of or Failure to Bond (1068); Break (1069); Fracture (1260)

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

Event Date 11/08/2021

Event Type  malfunction  

Event Description

(b)(4) an end user reported an issue with two peel-away sheaths that came from 8f low profile bioflo vortex port kits.During a procedure, the first sheath broke in the physician's hand; therefore, another one was pulled and it broke when the physician was attempting to pry it apart after it had been placed, using hemostats.The peel away portion is outside the patient body, therefore it was being peeled externally.Nothing broke off inside the patient.It was reported that the procedure was completed with another same device and the patient did not experience any adverse effects, harm, or require medical intervention as a result of this incident.This complaint is to evaluated (b)(4).

• Brand Name: OPTISEAL NSP BULK NON-STERILE, 8FR, 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: 13057476
• MDR Text Key: 286762809
• Report Number: 2183787-2021-00114
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093232
• 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: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1002636-003
• Device Lot Number: W5844425 OR W6280339
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1