MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CE0380ST, 3F-80CM PREM SYNTEL CATH; DXE

Model Number CE0380ST

Device Problem Difficult to Remove (1528)

Patient Problem Injury (2348)

Event Date 07/12/2017

Event Type  malfunction  

Manufacturer Narrative

No product is being returned for evaluation but lot # is provided.A device history report is to be reviewed by engineering.A final report will be sent once the results have been analyzed.

Event Description

Procedure performed: unk.Embolectomy catheter became stuck in artery.Consultant surgeon unable to remove.Possible cause unknown.Additional incision required to facilitate removal of catheter.Vein required to be harvested from patients arm to repair damage to artery.Additional information was received via email on 23jan2019 from distributor: the customer was not able to advise on the patient status."she does not know patients current status"."the catheter did not come into contact with any sharp object." "there was no difficulty inserting the catheter but the surgeon was unable to remove it when required to do so." patient status: unk type of intervention: additional incision required to facilitate removal.

Event Description

Procedure performed: unknown.Embolectomy catheter became stuck in artery.Consultant surgeon unable to remove.Possible cause unknown.Additional incision required to facilitate removal of catheter.Vein required to be harvested from patients arm to repair damage to artery.Additional information was received via email on 23jan2019 from distributor: the customer was not able to advise on the patient status."she does not know patients current status"."the catheter did not come into contact with any sharp object." "there was no difficulty inserting the catheter but the surgeon was unable to remove it when required to do so." patient status: unknown.Type of intervention: additional incision required to facilitate removal.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.As the event unit was not returned, testing was unable to be performed and the complainant¿s experience could not be replicated or confirmed.In the absence of the event unit, it is difficult to determine the exact root cause of the event.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.

• Brand Name: CE0380ST, 3F-80CM PREM SYNTEL CATH
• Type of Device: DXE
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 8291374
• MDR Text Key: 134564670
• Report Number: 2027111-2019-00333
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Public: (01)H699CE0380ST105(17)220430(30)01(10)1295726
• 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,other
• Type of Report: Initial,Followup
• Report Date: 04/12/2019

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 Expiration Date: 04/30/2022
• Device Model Number: CE0380ST
• Device Catalogue Number: 100745201
• Device Lot Number: 1295726
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/03/2019
• Initial Date FDA Received: 01/30/2019
• Supplement Dates Manufacturer Received: 01/03/2019
• Supplement Dates FDA Received: 04/12/2019
• Patient Sequence Number: 1