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MAUDE MDR 5932

MDR report key
5932
Report number
5932
Event key
0
Event type
3
Date of event
1992-12-31
Date received
1993-07-01
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BALLOON EXTRACTORWILSON COOKEMGPLV 4.8 200**

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11993-07-0101. *

Event Narratives#

D

Patient 1

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.