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

Model Number I300F85

Device Problems Disconnection (1171); Material Separation (1562)

Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)

Event Date 11/15/2019

Event Type  malfunction  

Manufacturer Narrative

Without the return of the product, it is not possible to determine if damages or defects exist on the product, nor can any manufacturing nonconformance, failure mode, root cause, or potential contributing factors be identified.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.Invasive procedures involve some patient risks.Although serious complications are relatively uncommon, the physician is advised, before deciding to insert or use the introducer, to consider the potential benefits in relation to the possible complications.The techniques for insertion, methods of using the introducer to obtain patient data information, and the occurrence of complications is well described in the literature.Additionally, these products are used by highly trained clinicians, experienced in identifying and mitigating any hazards that arise.Invasive procedures involve some patient risks.Although serious complications are relatively uncommon, the physician is advised to consider the potential benefits in relation to the possible complications.In this event the side arm of the introducer became detached from the main introducer sheath and the patient experienced some minor blood loss before the issue was identified.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 while the patient was under the drapes in the ¿theater¿, the side arm of the introducer disconnected from the main introducer sheath.There was some blood loss before the issue was identified.No patient injury was reported and demographics were requested and not provided.No additional details are known.The model and lot number were also not reported.It is unknown if the product is available for return evaluation.

Manufacturer Narrative

Additional information was obtained from the customer regarding the reported event.The model and lot number, as well as, patient demographics were obtained.It was clarified that the catheter introducer sheath had become disconnected at the hub between the body of the device and the one-way valve that ¿would normally be used for inserting a pa catheter.¿ the introducer had been placed in the patient¿s right internal jugular vein and the issue resulted in 600ml of blood loss.The clinician did not feel a blood transfusion or any other interventions were necessary and there was no patient injury.A new introducer was not placed.The product was discarded at hospital.A device history record review was completed and documented that the device met all specifications upon distribution.

Manufacturer Narrative

Reference capa-20-00141.

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 00610
• MDR Report Key: 9489933
• MDR Text Key: 188697959
• Report Number: 2015691-2019-04738
• 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: foreign,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 11/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2021
• Device Model Number: I300F85
• Device Lot Number: 62064202
• 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 Age: 66 YR