MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2017-01-23 for M1333A manufactured by Philips Medical Systems.
[65520798]
A follow up report will be submitted once the investigation is complete. (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[65520799]
The customer reported that an incident (death of a patient) occurred while a m1333a koala tip catheter was in use. It has not been confirmed yet that if the device malfunctioned or if the device was a contributing factor the patient? S death.
Patient Sequence No: 1, Text Type: D, B5
[73350622]
The customer reported that, after the placenta localization, the clinician introduced the product without any resistance following the procedure of the user guide. Within a half of a minute of insertion of the product, the baby reportedly went into a bradycardia condition. The patient was within 9 minutes at the operating room for a cesarean where the baby was born after 15 minutes, but the baby had died. There reportedly was a lesion at the placenta because of the product. Philips clinical evaluation of the information made available by the hospital was performed. Philips? Clinical opinion, the lesion was likely located in the umbilical vein (not placental vein), based on the timing of the events (bradycardia within 30 seconds). The lesion was likely caused by the iupc (intrauterine pressure catheter) device. The most reasonable conditions that would lead to an umbilical vein lesion by the iupc device are device-related (hard iupc tip) or application-related (failure to follow ifu). The available information does not support that either of these conditions were present during this incident. Therefore, it is not known why the iupc caused the lesion in the umbilical vein. As a result, we are considering this to be a malfunction for reporting purposes only.
Patient Sequence No: 1, Text Type: N, H10
[74180645]
The customer reported that, after the placenta localization, the clinician introduced the product without any resistance following the procedure of the user guide. Within a half of a minute of insertion of the product, the baby reportedly went into a bradycardia condition. The patient was within 9 minutes at the o. R. Room for a cesarean where the baby was born after 15 minutes, but the baby had died. There reportedly was a lesion at the placenta because of the product. Philips clinical evaluation of the information made available to philips by the hospital was performed. Philips? Clinical opinion is that the lesion was likely located in the umbilical vein (not placental vein as previously reported), based on the timing of the events (bradycardia within 30 seconds). It is possible that the lesion could have been caused by the iupc (intrauterine pressure catheter) device, but the possibility that the lesion was caused by other means could not be ruled out. According to philips? Supplier of this product, the two conditions could possibly lead to an umbilical vein lesion by the iupc device are either device-related (hard iupc tip) or application-related (failure to follow ifu). The available information does not support that either of these conditions were present during this incident. Therefore, if the iupc device caused the lesion in the umbilical vein, it is not known why or how this occurred. As a result, we are considering this to be a malfunction for reporting purposes only.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218950-2017-00523 |
| MDR Report Key | 6270846 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2017-01-23 |
| Date of Report | 2017-01-19 |
| Date of Event | 2016-10-07 |
| Date Mfgr Received | 2017-01-19 |
| Date Added to Maude | 2017-01-23 |
| 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 | MS. BETTY HARRIS |
| Manufacturer Street | 3000 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9786871501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NA |
| Generic Name | NA |
| Product Code | HGS |
| Date Received | 2017-01-23 |
| Model Number | M1333A |
| Lot Number | NOT AVAILABLE |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | 3000 MINUTEMAN ROAD ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Other | 2017-01-23 |