Complaint conclusion: as reported, the 6 x 20 mm 150 cm saber balloon was damaged.
The issue was further clarified as the device was kinked/bent, fractured at the tip.
There was no reported patient injury.
The malfunction was noticed during prep.
The device was not prepped normally (i.
E.
Maintain negative pressure).
There was no difficulty removing the product from the hoop, the protective balloon cover, or the stylet or any of the sterile packaging components.
The device was not used inside the patient.
The product was not returned for analysis.
A device history record (dhr) review of lot 17588608 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.
The reported ¿distal tip cracked during prep¿ could not be confirmed as the device was not returned for analysis.
The exact cause of the fractured tip could not be determined.
Based on the limited information available for review, handling factors may have contributed to the reported event.
According to the instructions for use, which is not intended as a mitigation, ¿prior to angioplasty, the catheter should be examined to verify functionality and integrity and ensure that its size and shape are suitable for the specific procedure for which it is to be used.
Do not use if product damage is suspected or evident.
Proper functioning of the catheter depends on its integrity.
Care should be used when handling the catheter.
Damage may result from kinking, stretching, or forceful wiping of the catheter.
Forceful handling can result in catheter separation and the subsequent need to use a snare or other medical interventional techniques to retrieve the pieces.
Always verify integrity of the catheter after removal.
¿ neither the dhr nor the information available suggests a design or manufacturing related cause for the reported event.
Therefore, no corrective/preventive action will be taken at this time.
|
As reported, the saber (6 mm 2 cm 150) balloon was damaged.
There was no reported patient injury.
The product will not be returned.
The device was kinked and bent, fractured at the tip.
The malfunction was noticed during prep.
The device was not prepped normally (i.
E.
Maintain negative pressure).
There was no difficulty removing the product from the hoop, the protective balloon cover, or the stylet or any of the sterile packaging components.
The device was not used inside the patient.
|