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

Model Number A4F03

Device Problem Separation Problem (4043)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/17/2022

Event Type  malfunction  

Manufacturer Narrative

The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be submitted upon completion.

Event Description

Procedure performed: ni.Event description: the embolectomy catheter was used thursday ((b)(6) 2022) night.When removed it was discovered that the tip had come off.Attempts to find the tip failed (xray etc).To be determined if product can be returned to usa (confirmation of no transmittable diseases missing so far).Type of intervention: attempts made to find the tip.Patient status: patient is doing fine but is still in the hospital.

Manufacturer Narrative

The event unit returned to applied medical for evaluation.Visual inspection of the event unit confirmed that the balloon had ruptured, and the spring tip had separated.Based on the evaluation of the returned unit, it is likely that the maximum pull force for the event unit was exceeded, which caused the balloon to rupture.Applied medical was reviewed the details surrounding the spring tip separation and is unable to determine the root cause of the spring tip separation based on the evaluation of the returned unit.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

Event Description

Procedure performed: ni event description: the embolectomy catheter was used thursday ((b)(6) 2022) night.When removed it was discovered that the tip had come off.Attempts to find the tip failed (xray etc).To be determined if product can be returned to usa (confirmation of no transmittable diseases missing so far).Additional information received via email on 13apr2022.There was no damage to the vessel.The surgeon did not have any difficulty inserting or removing the catheter.No photos are available of the device.Product is available for return.Type of intervention: attempts made to find the tip.Patient status: patient is doing fine but is still in the hospital.

• 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
• Manufacturer Contact: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 13943826
• MDR Text Key: 288180500
• Report Number: 2027111-2022-00532
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Public: (01)00H699A4F0310T(17)240819(30)01(10)1347024
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K901627
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A4F03
• Device Catalogue Number: 100564901
• Device Lot Number: 1347024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/21/2022
• Initial Date FDA Received: 03/29/2022
• Supplement Dates Manufacturer Received: 03/21/2022
• Supplement Dates FDA Received: 08/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1