INFLATION DEVICES
Received Aug 10, 2006 · Event occurred Jul 20, 2006
Report 6000143-2006-00001 · MDR key 746655
Device
Generic name
Achalasia Pneumatic Hand Pump
Manufacturer
Boston ScientificModel number
*Catalog number
5320
Lot number
UNK
Product problems
- Inflation Problem
Patient
UNKNOWN
- Death
- Perforation
Narrative
Description of Event or Problem
THE COMPLAINANT REPORTED THAT THE INFLATION DEVICE WAS BEING INFLATED AND COULD NOT INFLATE TO THE PRESCRIBED PRESSUE. THE PROCEDURE WAS COMPLETED WITH A GOOD RESULT, BUT WITH A NOTICEABLE MUCOFAL TEAR. NO LEAK WAS NOTICED, CONFIRMED BY INJECTION OF CONTRAST AND SCREENING. THE PATIENT EXPIRED THE NEXT DAY ON THE WARD WITH AN OPHAGEAL PERFORATION.
Additional Manufacturer Narrative
THIS DEVICE HAS BEEN RECEIVED BY THIS MANUFACTURER, BUT AN EVALUATION HAS NOT YET BEEN PERFORMED. THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND WE ARE UNABLE TO DETERMINE IF THE DEVICE MET ITS SPECIFICATIONS. SHOULD FURTHER RELEVANT DETAILS BECOME AVAILABLE; A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED UNDER THE APPROPRIATE SEQUENCE NUMBER. WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT AT THIS TIME. OUR DIRECTIONS FOR USE OUTLINE APPROPRIATE PLACEMENT, ACCESS AND MAINTENANCE PROCEDURES.