MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW; CATHETER, PERCUTANEOUS

Model Number IPN000134

Device Problems Product Quality Problem (1506); Detachment of Device or Device Component (2907)

Patient Problems Hemorrhage/Bleeding (1888); Loss of consciousness (2418)

Event Date 03/25/2024

Event Type  Injury  

Event Description

This patient had known, severe calcification of the femoral arteries.On a recent catheterization, sheath removal was also complex.The interventional team elected to use the arrow braided sheath to reinforce the stability and integrity of the access for this procedure, which was appropriate.The team was at the bedside removing the femoral sheath when a unique situation transpired, where the sheath hub detached from the shaft of the sheath.The shaft of the sheath remained in the patient and the patient began to lose blood in a pulsatile fashion from this location.Pressure was held.The patient briefly became unresponsive and was given 1 amp epinephrine.Vascular surgery was called to the bedside and was able to retrieve the sheath.Manual pressure was held for approximately 40 minutes.The patient was given 2 units of prbcs and was started on levophed.The patient was transferred to the ccu for close monitoring.We have not previously seen this situation occur at (b)(6), and it clearly represents a manufacturing fallibility in the sheath, rather than a user error or inappropriate usage.The team removing the sheath is very experienced in sheath removal.

Event Description

This patient had known, severe calcification of the femoral arteries.On a recent catheterization, sheath removal was also complex.The interventional team elected to use the arrow braided sheath to reinforce the stability and integrity of the access for this procedure, which was appropriate.The team was at the bedside removing the femoral sheath when a unique situation transpired, where the sheath hub detached from the shaft of the sheath.The shaft of the sheath remained in the patient and the patient began to lose blood in a pulsatile fashion from this location.Pressure was held.The patient briefly became unresponsive and was given 1 amp epinephrine.Vascular surgery was called to the bedside and was able to retrieve the sheath.Manual pressure was held for approximately 40 minutes.The patient was given 2 units of prbcs and was started on levophed.The patient was transferred to the ccu for close monitoring.We have not previously seen this situation occur at [redacted name], and it clearly represents a manufacturing fallibility in the sheath, rather than a user error or inappropriate usage.The team removing the sheath is very experienced in sheath removal.

• Brand Name: ARROW
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 19002773
• MDR Text Key: 338891048
• Report Number: 19002773
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN000134
• Device Catalogue Number: CL-07611
• Device Lot Number: 14F23L0168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/27/2024
• Event Location: Hospital
• Date Report to Manufacturer: 03/29/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/29/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/19/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 36 KG
• Patient Race: White