MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR CATHETER CONTAMINATION SHIELD, 80 CM; CATHETER, PERCUTANEOUS

Model Number CC0280

Device Problems Loose or Intermittent Connection (1371); Contamination /Decontamination Problem (2895); Device Difficult to Maintain (3134)

Patient Problems No Consequences Or Impact To Patient (2199); Discomfort (2330)

Event Date 02/10/2020

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.A review of the manufacturing records indicated that the product met specifications upon release.Swan-ganz pacing thermodilution (td) catheters serve as diagnostic and therapeutic tools in the management of critically ill patients deficient fixation between the introducer and the pacing catheter could cause loss of capture of the pacemaker leading to inadequate pacing of the patient potentially causing hemodynamic instability.These products are used by highly trained clinicians, experienced in identifying and mitigating any hazards that arise during use.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 in a patient, this contamination shield did not secure the non-edwards pacing catheter as tightly as the contamination shield supplied with the introflex does.Therefore, while moving the patient, it was detected by an endoscopy that the catheter was moved forward 8cm from its original position causing some discomfort to the patient.There was no loss-of-pacing, no cardiac-arrest, and no endocardium damage reported.The contamination shield used was not the one originally supplied with the introflex introducer since it fell on the floor when trying to insert it.There was no allegation of patient injury.The device was not available for evaluation since it was discarded by the customer.The sales rep confirmed with the customer that this is normal practice, introducer is sewn to the patient and the catheter is fixed by screwing the black rubber of the shield to the catheter.After the sales rep visit, user will use adjustable introducer that has its tightening ring to ensure greater fixation.

Manufacturer Narrative

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

• Brand Name: CATHETER CONTAMINATION SHIELD, 80 CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• MDR Report Key: 9806326
• MDR Text Key: 193699080
• Report Number: 2015691-2020-10866
• 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: 02/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/21/2020
• Device Model Number: CC0280
• Device Lot Number: 60225808
• 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