MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR INTRO-FLEX PERCUTANEOUS SHEATH; INTRODUCER, CATHETER

Model Number I300F85

Device Problem Contamination (1120)

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

Event Date 12/06/2021

Event Type  malfunction  

Manufacturer Narrative

The device was not available for evaluation, since it was discarded at hospital.Without return of the product, edwards is unable to perform a complete investigation of the reported event.It is not possible to determine what factors may have contributed to it, and therefore no actions could be planned.An engineering investigation has been initiated to consider any potential factors that may have contributed to this complaint.

Event Description

As reported, before use on patient with this introducer, a hair was found inside the fluid path.There was no allegation of patient injury.The device was not available for evaluation since it was discarded and no pictures were available.Patient demographics were not provided by the hospital, since this issue was detected before use on patient.

Manufacturer Narrative

The device was not available for evaluation, since it was discarded at hospital.Without return of the product, edwards is unable to perform a complete investigation of the reported event.It is not possible to determine what factors may have contributed to it, and therefore no actions could be planned.Since the device was discarded and no pictures were available; therefore a product non-conformance or device failure could not be confirmed.The manufacturing records were reviewed and there is no indication of a related nonconformance.All process parameters were met and inspections passed successfully.Additionally, as part of the manufacturing process, these units go through a packaging visual inspection process.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.H3 other text : device was discarded at hospital.

• Brand Name: INTRO-FLEX PERCUTANEOUS SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 13117594
• MDR Text Key: 283509483
• Report Number: 2015691-2021-07114
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: I300F85
• Device Lot Number: 63521036
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2020
• 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