MAUDE Adverse Event Report: MEDCOMP 12.5FX28CM HEMO-CATH; HEMO-CATH LT

Model Number SL28E.

Device Problem Break (1069)

Patient Problems Pulmonary Embolism (1498); Air Embolism (1697)

Event Date 07/20/2017

Event Type  Injury  

Manufacturer Narrative

Additional information has been requested from the distributor.When the investigation is complete a final report will be submitted.

Event Description

Patient with hodgkin lymphoma, approx.1 week following autologous stem cell harvest.Attending hospital for nuclear medical gfr test.Shortly after first appointment with nuclear medicine, patient went outside hospital to use e-cigarette.Patient became acute short of breath and collapsed.Admitted to a&e resus with symptoms of acute pulmonary embolism and thrombolysed.Echocardiogram reported bubble artefact in rv.Required intubation and ventilation.Subsequent ctpa showed no evidence of pulmonary embolism.Apheresis central catheter was noted to be bleeding since thrombolysis.The following evening, with persistent bleeding, it was noted that there was a fracture in the apheresis catheter.

Manufacturer Narrative

The device involved in the incident was not returned for evaluation.The clinician noted, on a drawing of the device, the location of the fracture to be (roughly) somewhere between the hub and the cuff.The length of time the catheter was implanted was not provided.This family of devices is 100% leak tested during the manufacturing process.The report indicated that the patient went outside the hospital to smoke and during that time experienced the medical issue.The patient was treated for pulmonary embolism.At some point the catheter was noted to be bleeding and the fracture was noted.It is possible that the device was damaged sometime during the treatment of the patient.Without an evaluation of the device involved we are unable to determine the cause or factors that may have contributed to this event.

• Brand Name: 12.5FX28CM HEMO-CATH
• Type of Device: HEMO-CATH LT
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• Manufacturer (Section G): MEDCOMP; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 6896845
• MDR Text Key: 87461738
• Report Number: 2518902-2017-00051
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00884908045994
• UDI-Public: 884908045994
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/20/2021
• Device Model Number: SL28E.
• Device Catalogue Number: SL28E.
• Device Lot Number: MHVK910
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2016
• 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): Life Threatening; Required Intervention