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

Model Number I300F85

Device Problem Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 06/06/2022

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.

Event Description

As reported, before use in patient of this introducer, the packaging was not tightly sealed.The doctor was worried about the possibility of contamination.There was no allegation of patient injury.Patient demographics unable to be obtained.The device was available for evaluation.

Manufacturer Narrative

One introducer was received by our product evaluation laboratory for a full examination.The report of opened seal was confirmed.Package was received with partially open seal.The tyvek lid was open at bottom right corner.Adhesive was evident at the open seal area.The adhesive transfer appeared complete without any visual interruption.There was no other visible abnormality from the package.In general, packaging non-conformances that results in a breach of the sterile package (i.E.Pinhole, tear or seal issue) have the potential to result in a serious infection.In this case, there is evidence that packaging was damaged in an extent that made it easily possible for edwards quality control personnel or the user of the device to detect the non-conformance.The packaging is damaged in a way, that it is always detected prior to use and could not go undetected.As such, this event is no longer considered reportable and a corrected supplemental report is being submitted.

• 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 PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 14945087
• MDR Text Key: 304446543
• Report Number: 2015691-2022-06651
• 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
• Type of Report: Initial,Followup
• Report Date: 08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: I300F85
• Device Lot Number: 63226377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1