MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-04-24 for ALERT INTERNAL CARDIOVERSION CATHETER AL-SP75149 manufactured by Dot Medical Products Ltd.
[73490877]
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.
Patient Sequence No: 1, Text Type: N, H10
[73490878]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006044395-2017-00001 |
| MDR Report Key | 6515834 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-04-24 |
| Date of Report | 2017-04-21 |
| Date of Event | 2016-10-05 |
| Date Mfgr Received | 2017-01-23 |
| Date Added to Maude | 2017-04-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. LILIANA OMAR |
| Manufacturer Street | 5353 WAYZATA BLVD. #505 |
| Manufacturer City | MINNEAPOLIS MN 554161334 |
| Manufacturer Country | US |
| Manufacturer Postal | 554161334 |
| Manufacturer Phone | 9527468080 |
| Manufacturer G1 | DOT MEDICAL PRODUCTS LTD. |
| Manufacturer Street | SILK POINT QUEENS AVENUE |
| Manufacturer City | MACCLESFIELD, SK102BB |
| Manufacturer Country | UK |
| Manufacturer Postal Code | SK10 2BB |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALERT INTERNAL CARDIOVERSION CATHETER |
| Generic Name | SYSTEM,PACING,TEMPORARY,ACUTE,INTERNAL ATRIAL DEFIBRILLATION |
| Product Code | MTE |
| Date Received | 2017-04-24 |
| Model Number | AL-SP75149 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DOT MEDICAL PRODUCTS LTD |
| Manufacturer Address | SILK POINT QUEENS AVENUE MACCLESFIELD, GB-CHS SK102BB UK SK10 2BB |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2017-04-24 |