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

Catalog Number UNKNOWN INDEFLATOR

Device Problems Break (1069); Leak/Splash (1354); Loose or Intermittent Connection (1371)

Patient Problems Air Embolism (1697); Arrhythmia (1721); Vascular Dissection (3160)

Event Date 11/18/2022

Event Type  Injury  

Event Description

It was reported through a post market clinical follow up (pmcf) evaluation report identifying the 20/30 indeflator device that may be related to the following: leak, loose/intermittent connection, break, issue with pressure/measure accuracy, other unspecified device issues, which could potentially lead to air embolism, arrhythmias, dissection and other unspecified adverse patient effects.Details are listed in the attached pmcf, titled post-market clinical follow-up evaluation report accessories and indeflators please see the attached post market clinical follow up evaluation report for specific information.

Manufacturer Narrative

Date of event ¿ estimated.The unique device identifier (udi) is unknown because the part number and lot number were not provided.The device was not returned for analysis.A review of the lot history record and similar incident review of the reported lot could not be conducted because the part and lot number was not provided.Due to the limited information available, the investigation determined a conclusive cause for the reported difficulties cannot be determined.Additionally, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.As multiple devices were captured in the pmcf report.Additional reports were filed under manufacturing reference numbers (b)(4), (b)(4).Pmcf attachment title: post-market clinical follow-up evaluation report accessories and indeflators.

• 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: 16665733
• MDR Text Key: 312541259
• Report Number: 2024168-2023-03381
• Device Sequence Number: 1
• Product Code: MAV
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K961471
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN INDEFLATOR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/10/2023
• Initial Date FDA Received: 04/03/2023
• 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