MAUDE Adverse Event Report: APPLIED MEDICAL SYNTEL THROMBECTOMY, 4F-40CM; THROMBECTOMY CATHETER, CODE:DXE

Model Number A4544

Device Problems Device Operates Differently Than Expected (2913); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/28/2014

Event Type  malfunction  

Event Description

Graft declot - "while declotting the graft, the end of the fogarty cath broke exposing a spring that attached to the patients artery.The physician had to open the graft to remove the spring." intervention - "an incision was made to pull out the spring from the patient." patient status - "patient is doing ok.".

Manufacturer Narrative

Ra has just received the incident device and has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of investigation.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when the initial report was submitted, then the supplemental report will be submitted to the fda.

Manufacturer Narrative

Investigation summary: the event unit was returned for evaluation.Upon inspection, engineering confirmed that the spring tip was detached from the catheter and found that the catheter was bent close to the proximal winding and the spring tip had been stretched.The balloon had a radial rupture through the midsection and a portion was inverted over the distal rubber tip.The balloon, the distal and proximal windings were still attached to the catheter shaft and spring tip.All catheters undergo a 100% visual inspection and leak testing during production.The catheters are designed in such a way that the proximal winding will slip or the balloon will burst under excessive force.This design prevents the force from being applied to the catheter body and breaking inside the patient and also prevents excessive force from being applied to the vessel itself.Therefore, to break the catheter tip a considerable amount of force must be placed on the catheter.The instructions for use (ifu) cautions the user that balloon degradation and rupture may result from exposure to adverse environmental conditions, excessive handling, or deposits within the vessel.This document represents our final report.

• Brand Name: SYNTEL THROMBECTOMY, 4F-40CM
• Type of Device: THROMBECTOMY CATHETER, CODE:DXE
• Manufacturer (Section D): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer (Section G): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: 22872 avenida empresa; rancho santa margarita, CA 92688 ; 949713-667
• MDR Report Key: 3747366
• MDR Text Key: 4469864
• Report Number: 2027111-2014-00188
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: A4544
• Device Catalogue Number: 100667601
• Device Lot Number: 1171172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2014
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/28/2014
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Hospitalization