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

Model Number ID4030

Device Problem Deflation Problem (1149)

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

Event Date 03/30/2021

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 06/2023).

Event Description

It was reported that during preparation for an angioplasty procedure, the pta balloon allegedly unable to deflate.It was further reported that another balloon was used to complete the procedure.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: two devices were returned for evaluation.The devices were visually evaluated and no anomalies were noted.During functional testing, sample 1 was able to be inflated to rbp but it was noted the device would not deflate fully.However, sample 2 was noted to inflate and deflate without any issues.The investigation is confirmed for the deflation issue, as on of the sample was noted to not fully delate after being inflated to rbp.Based upon the available information a definitive root cause could not be determined.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: 06/2023), g3.H11: b5.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.H3 other text : see h10.

Event Description

It was reported that during preparation for an stent placement procedure, the balloon allegedly unable to deflate.It was further reported that the balloons were deflated using a large plastipak syringe.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: two devices were returned for evaluation.The devices were visually evaluated and no anomalies were noted.During functional testing, sample 1 was able to be inflated to rbp but it was noted the device would not deflate fully.However, sample 2 was noted to inflate and deflate without any issues.The investigation is confirmed for the deflation issue, as on of the sample was noted to not fully delate after being inflated to rbp.Based upon the available information a definitive root cause could not be determined.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: 06/2023).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.

Event Description

It was reported that during preparation for an angioplasty procedure, the pta balloon allegedly unable to deflate, it was further reported that another balloon was used to complete the procedure.There was no reported patient injury.

• 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: 11730883
• MDR Text Key: 247455685
• Report Number: 2020394-2021-00925
• 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,Followup
• Report Date: 06/18/2021

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: PID2006071X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2021
• Initial Date Manufacturer Received: 03/31/2021
• Initial Date FDA Received: 04/27/2021
• Supplement Dates Manufacturer Received: 05/31/2021; 06/18/2021
• Supplement Dates FDA Received: 06/02/2021; 06/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other