MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR PERCUTANEOUS SHEATH INTRODUCER SET; CATHETER, PERCUTANEOUS

Model Number I451BF6

Device Problems Device Slipped (1584); Unstable (1667); Improper or Incorrect Procedure or Method (2017); No Pacing (3268)

Patient Problem Cardiac Arrest (1762)

Event Date 03/02/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation; it was discarded at the hospital.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.No corrective actions will be taken at this time.A review of the manufacturing records indicated that the product met specifications upon release.Invasive procedures involve some patient risks.Although serious complications are relatively uncommon, the physician is advised, before deciding to perform the procedure, to consider the potential benefits in relation to the possible complications.In this case, the sales rep observed that the contamination shield of a 6 french introducer was put on the bipolar catheter incorrectly.All icu staff has been trained on the use of the device after this incident and the patient was in stable condition.The ifu clearly states to ¿extend the distal end of the catheter contamination shield towards the introducer valve.Align the valve cap guides with the grooves in the distal adapter of the contamination shield.Push the distal adapter over the valve cap and rotate until securely locked into place.Extend the proximal end of the catheter contamination shield to desired length, ad secure proximal tuohy borst adapter to the catheter.¿ 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.

Event Description

It was reported that during use of an introducer, the swan ganz pacing catheter slipped out and stopped pacing.The patient experienced a cardiac arrest that was resolved once pacing was re-started.The sales rep visited the site and it looked like the contamination shield from a 6 french introducer was put on the bipolar catheter incorrectly upside down.The introducer was not able to be locked and the catheter was not secure.Tape was used to keep the contamination shield in place.The tuohy borst valve was not tightened to secure the catheter in place, so the catheter slipped and stopped pacing the patient.Once noted, the same catheter was re-inserted and pacing resumed.The catheter was secured with tape again.The patient is stable.All icu staff has been trained on the use of the device after this incident.Patient demographics were unable to be obtained.The device was discarded at the hospital.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: PERCUTANEOUS SHEATH INTRODUCER SET
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco PR
• MDR Report Key: 9872193
• MDR Text Key: 194791186
• Report Number: 2015691-2020-11105
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K831729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/21/2021
• Device Model Number: I451BF6
• Device Lot Number: 62110374
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other