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

Model Number ID4030

Device Problem Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 11/28/2022

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 device has been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.(expiry date: 06/2025).

Event Description

It was reported that prior to an angioplasty procedure, the package in the box were opened past the seal and no longer sterile.There was no patient contact.

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 was returned for evaluation.The device was returned in the packaging.The bottom portion of the tyvek packaging was noted to be unsealed.Evidence of the seal was noted on the packaging.No other anomalies were noted.2 electronic images were also provided for review.The bottom portion of the tyvek sealing is noted to be peeled in both photos.Therefore, the investigation is confirmed for the reported peeling sterile barrier layer.The definitive root cause for the peeling sterile barrier could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 06/2025), g3, h6 (method) h11: b5, h6 (result, conclusion) h11: section a through f - the information provided by bd represents all of 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 prior to an angioplasty procedure, the device package was allegedly peeled back past sterile barrier at the opening lip.There was no patient contact.

• Brand Name: PRESTO INFLATION DEVICE
• Type of Device: INFLATION DEVICE
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): FOREFRONT MEDICAL TECHNOLOGY; changzhou ; CH
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 16020636
• MDR Text Key: 308367228
• Report Number: 2020394-2022-01001
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 00801741095009
• UDI-Public: (01)00801741095009
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143522
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/22/2023

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: ID2206105X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2022
• Initial Date FDA Received: 12/21/2022
• Supplement Dates Manufacturer Received: 02/22/2023
• Supplement Dates FDA Received: 02/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1