MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. PRESTO INFLATION DEVICE

Model Number ID4030

Device Problems Suction Problem (2170); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/12/2020

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 05/2023).

Event Description

It was reported that during an angioplasty procedure, the device allegedly had suction problem.There was no reported patient injury.

Event Description

It was reported that during an angioplasty procedure, the device allegedly had suction problem.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one presto inflation device has returned for evaluation.On the visual evaluation the device appeared to have saline residue, no specific anomalies noted.On the functional evaluation, the button was able to be easily toggled and the piston was attempted to retract but it was unsuccessful, then the handle was then twisted counter clock approximately 360 degrees to unjam the piston, then the piston retracted, and the device attempts to fill and pressurizes but no water would aspirate, a blockage was felt.Upon disassembly of device, no specific anomalies noted.However, on inserting the piston was attempts to insert and felt a blockage at the connection point from the inflation device and high-pressure tubing.Attempts made to remove the foreign material, but it was unsuccessful, then high pressure tubing was used to pull out the foreign material.On further the mandril would not fully push the foreign material out of the high-pressure tubing, the tubing was cut.Both ends was examined, cut one was clear while the remaining cut connected to the inflation device clearly had the blockage.The mandril was once again used to push the foreign material out of the end of the cut of the tubing.The foreign material was ejected out.It was noted to be clear as if it were glue, it contained contrast crystals.Water was added to it to test if the foreign material would dissolve.The contrast did dissolve, leaving the foreign material behind which appeared to be clear and glue-like material.After removal of the blockage the device was reassembled and the device able to fill and pressurize.Therefore, the investigation has confirmed reported suction issue as the piston would not retract and it was retraced by twisting the piston twisted counter clockwise to unjam the piston.The investigation was also conformed for the identified foreign material as glue like material was removed from the connection point on the device which returned for evaluation.The definitive root cause for the reported suction problem and identified foreign material could not be determined based upon available information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 05/2023), g3.H11: h6 (result, conclusion).H11: section a through f the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: PRESTO INFLATION DEVICE
• Type of Device: INFLATION DEVICE
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11305866
• MDR Text Key: 231111789
• Report Number: 2020394-2021-00199
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 00801741095009
• UDI-Public: (01)00801741095009
• Combination Product (y/n): N
• PMA/PMN Number: K143522
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ID4030
• Device Catalogue Number: ID4030
• Device Lot Number: PID2005048X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Initial Date Manufacturer Received: 01/14/2021
• Initial Date FDA Received: 02/10/2021
• Supplement Dates Manufacturer Received: 05/20/2021
• Supplement Dates FDA Received: 05/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other