MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES A4F03, 3F-80CM, (PREM) SYNTEL CATHETER; CATHETER, EMBOLECTOMY

Model Number A4F03

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Ischemia (1942); Sepsis (2067)

Event Date 11/14/2019

Event Type  Injury  

Manufacturer Narrative

The incident device is anticipated to return.A follow-up report will be provided upon completion of investigation.

Event Description

Procedure performed: "fem-pop bypass operation." "the patient underwent a fem-pop bypass operation, and on passing the embolectomy catheter distally inflated the balloon with 0.25ml saline, on withdrawing the catheter, the balloon and tip became detached and only the spring on the tip remained on removal from arteriotomy.This was placed on the trolly and another embolectomy of the same size and lot number was immediately passed and inflated according to ifu and embolus removed, however could only proceed to where previously deployed but the balloon and tip were retained it appears.No x-ray taken.Patients foot partially pinked up however they remain on itu.It is felt the patient would have returned to the ward by now had this not occured." "it is unknown whether the detached balloon and tip is causing further restriction of blood flow to the foot, there was a previous embolus which required removing in the first place." "the foot is still at risk of ischaemia and ? potential damage from the detached tip." hospital: [name], (b)(6).The complaint was submitted to us by [name] under reference number (b)(4).Since applied sold this catheter directly to [name], applied will directly communicate with this facility about this complaint.Additional information received via email from territory manager 28nov19: the hospital confirmed with us that the product had been collected last week on friday 22nd, this must have been sent back to [name] as they mentioned that they had received our box in a box but it had been sent back down empty due to collection having already happened.Patient status: patient is still in itu (day 13) and is in critical condition.Patient is now being aggressively treated for sepsis.Patient has lost flow of blood to the lower limb of the leg.Additional procedural details: vessel was not heavily calcified, only thrombus.The surgeon had inflated the balloon, pulled back to dislodge the clot and on removing the catheter felt a pop.When it had been removed the spring tip looked as though it was uncoiled.Other: x-rays have now been taken and the balloon and tip are visible on these.The team have stated that the patient¿s current condition is as of a result of the incident.[name] will be seeking updates from the itu team tomorrow regarding the patient status and of course will update us should the worst happen.[name] have been communicating with the team as well.Additional information received from territory manager via telephone 02dec19: the territory manager followed up with the hospital and the contact has advised that the patient has undergone a second procedure to perform an amputation of the leg.The or team are required to submit a report to their governance department.Patient status: "the foot is still at risk of ischaemia and ? potential damage from the detached tip." intervention: "patients foot partially pinked up however they remain on itu.It is felt the patient would have returned to the ward by now had this not occured.".

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Upon visual inspection, engineering confirmed the complainant's experience of device breakage.The tip of the event unit was missing and the spring was elongated.Based on the condition of the returned unit, it is likely that the maximum pull force for the device was exceeded.The instructions for use (ifu) states "do not exceed maximum pull force specifications as balloon rupture and catheter separation may result." however, the exact root cause of the spring failure could not be determined.However, based on additional information provided by the customer and further discussion with a surgeon, it is not suspected that the event unit contributed to limb amputation.

Event Description

Procedure performed: "fem-pop bypass operation." event description: "the patient underwent a fem-pop bypass operation, and on passing the embolectomy catheter distally inflated the balloon with 0.25ml saline, on withdrawing the catheter, the balloon and tip became detached and only the spring on the tip remained on removal from arteriotomy.This was placed on the trolly and another embolectomy of the same size and lot number was immediately passed and inflated according to ifu and embolus removed, however could only proceed to where previously deployed but the balloon and tip were retained it appears.No x-ray taken.Patients foot partially pinked up however they remain on itu.It is felt the patient would have returned to the ward by now had this not occured." "it is unknown whether the detached balloon and tip is causing causing further restriction of blood flow to the foot, there was a previous embolus which required removing in the first place." "the foot is still at risk of ischaemia and ? potential damage from the detached tip." hospital: [name], united kingdom.The complaint was submitted to us by [name] under reference number 19-11-019.Since applied sold this catheter directly to [name], applied will directly communicate with this facility about this complaint.Additional information received via email from territory manager 28nov19: the hospital confirmed with us that the product had been collected last week on friday 22nd, this must have been sent back to [name] as they mentioned that they had received our box in a box but it had been sent back down empty due to collection having already happened.Patient status: patient is still in itu (day 13) and is in critical condition.Patient is now being aggressively treated for sepsis.Patient has lost flow of blood to the lower limb of the leg.Additional procedural details: vessel was not heavily calcified, only thrombus.The surgeon had inflated the balloon, pulled back to dislodge the clot and on removing the catheter felt a pop.When it had been removed the spring tip looked as though it was uncoiled.Other: x-rays have now been taken and the balloon and tip are visible on these.The team have stated that the patient¿s current condition is as of a result of the incident.[name] will be seeking updates from the itu team tomorrow regarding the patient status and of course will update us should the worst happen.[name] have been communicating with the team as well.Additional information received from territory manager via telephone 02dec2019: the territory manager followed up with the hospital and the contact has advised that the patient has undergone a second procedure to perform an amputation of the leg.The or team are required to submit a report to their governance department.Patient status: "the foot is still at risk of ischaemia and ? potential damage from the detached tip." intervention: "patients foot partially pinked up however they remain on itu.It is felt the patient would have returned to the ward by now had this not occured.".

• Brand Name: A4F03, 3F-80CM, (PREM) SYNTEL CATHETER
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 9454549
• MDR Text Key: 172188692
• Report Number: 2027111-2019-00660
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Public: (01)H699A4F0310T(17)220524(30)01(10)1297497
• Combination Product (y/n): N
• PMA/PMN Number: K901627
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 02/19/2020

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 Expiration Date: 05/24/2022
• Device Model Number: A4F03
• Device Catalogue Number: 100564901
• Device Lot Number: 1297497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/19/2019
• Initial Date FDA Received: 12/11/2019
• Supplement Dates Manufacturer Received: 11/19/2019
• Supplement Dates FDA Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability