MAUDE Adverse Event Report: DOT MEDICAL PRODUCTS LTD ALERT INTERNAL CARDIOVERSION CATHETER; SYSTEM,PACING,TEMPORARY,ACUTE,INTERNAL ATRIAL DEFIBRILLATION

Model Number AL-SP75149

Device Problems Difficult To Position (1467); Difficult to Advance (2920)

Patient Problems Death (1802); Great Vessel Perforation (2152); Rupture (2208)

Event Date 10/05/2016

Event Type  Death  

Manufacturer Narrative

In the absence of the catheter itself or a record of the batch number, dot medical has reviewed the manufacturing batch documentation for all the alert internal cardioversion catheters supplied to (b)(6) hospital which would have been within shelf life at the time of the incident.No adverse manufacturing events occurred with any of the supplied devices.There were no manufacturing changes involving any of these supplied devices.There were no changes to either labelling or ifu content with these devices.There are no similar incidents under dot medical ownership since 2008.Due to lack of availability of the device and based on the information supplied by the hospital, no further investigation is possible.The device was not returned.

Event Description

This was an elective patient who was having an af ablation which was performed.To confirm the functional effect of the ablation, an external cardioversion was unsuccessful therefore the decision was to perform an internal cardioversion.With the stylet fully engaged, the ep consultant cardiologist attempted to advance the alert® internal cardioversion catheter into the pulmonary artery but describes having difficulty at all stages.He then uses a whisper guide wire¿ but continues to have difficulty.The nurse identifies the patient has haemoptysis followed by protracted cardiac arrest and is transferred emergently to cardiothoracic theatres where a salvage pneumonectomy was performed.The pathologist confirms iatrogenic rupture of the pulmonary artery.It was confirmed that the internal cardioversion shock was not delivered.Withdrawal of treatment after 8 days due to a non-recoverable hypoxic brain injury, patient died.

• Brand Name: ALERT INTERNAL CARDIOVERSION CATHETER
• Type of Device: SYSTEM,PACING,TEMPORARY,ACUTE,INTERNAL ATRIAL DEFIBRILLATION
• Manufacturer (Section D): DOT MEDICAL PRODUCTS LTD; silk point; queens avenue; macclesfield, gb-chs SK10 2BB; UK SK10 2BB
• Manufacturer (Section G): DOT MEDICAL PRODUCTS LTD.; silk point; queens avenue; macclesfield, SK10 2BB; UK SK10 2BB
• Manufacturer Contact: liliana omar ; 5353 wayzata blvd. #505; minneapolis, MN 55416-1334 ; 9527468080
• MDR Report Key: 6515834
• MDR Text Key: 73490877
• Report Number: 3006044395-2017-00001
• Device Sequence Number: 1
• Product Code: MTE
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P990069
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/21/2017

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?: No
• Device Operator: No Information
• Device Model Number: AL-SP75149
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/23/2017
• Initial Date FDA Received: 04/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: INITIAL ABLATION DEVICE; WHISPER GUIDE WIRE¿
• Patient Outcome(s): Death