PLV 4.8 200

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-07-01 for PLV 4.8 200 manufactured by Wilson Cook.

Event Text Entries

[16760653] During an ercp procedure the balloon extractor tubing broke while still in the ercp scope. The balloon did not deflate. The scope had to be removed, proximal end of the balloon tubing was pulled out through the mouth. Under floroscopy the balloon was removed from the common duct through the pailla & removed from the patient. Invalid data - regarding single use labeling of device. Patient medical status prior to event: invalid data. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. Invalid data - regarding whether event presents imminent hazard. Invalid data - whether device used as labeled/intended. Device was evaluated after the event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 5932
• MDR Report Key: 5932
• Date Received: 1993-07-01
• Date of Report: 1993-04-30
• Date of Event: 1992-12-31
• Report Date: 1993-04-30
• Date Reported to FDA: 1993-04-30
• Date Added to Maude: 1993-07-29
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Generic Name: BALLOON EXTRACTOR
• Product Code: EMG
• Date Received: 1993-07-01
• Model Number: PLV 4.8 200
• Device Availability: *
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 5630
• Manufacturer: WILSON COOK

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. No Informationnvalid Deathata	1993-07-01