MAUDE Adverse Event Report: ABBOTT VASCULAR 20/30 PRIORITY PACK INDEFLATOR; ACCESSORIES

Catalog Number UNK INDEFLATOR PPAK 20/30

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 01/05/2021

Event Type  malfunction  

Manufacturer Narrative

Estimated date.The udi number is not known as the part and lot number were not provided.The device was not returned for analysis.A review of the lot history record and similar incident query of the reported lot could not be conducted because the part and lot number was not provided.It is possible that the reported air remaining in the system resulted in the reported balloons are slow to inflate and require numerous turns of the handle; however as the device was not returned for analysis this cannot be confirmed.The investigation determined a conclusive cause for the reported difficulties/leak cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.Two medwatch reports were filed to capture the indeflators referenced in the general comment.Na.

Event Description

It was reported via a general comment that while trying to inflate balloons with indeflator 20/30s, if any air remains in the system the balloons are slow to inflate and require numerous turns of the handle.The indeflators were reportedly prepped as per the instructions for use; however, air remained in the system.There were no adverse patient effects reported related to the general comment.No additional information was provided.

• Brand Name: 20/30 PRIORITY PACK INDEFLATOR
• Type of Device: ACCESSORIES
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 11562665
• MDR Text Key: 243616489
• Report Number: 2024168-2021-02338
• Device Sequence Number: 1
• Product Code: MAV
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K961471
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/24/2021

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 Catalogue Number: UNK INDEFLATOR PPAK 20/30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2021
• Initial Date FDA Received: 03/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other