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

Model Number 1003327

Device Problems Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017); Noise, Audible (3273)

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

Event Date 02/09/2021

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that during the procedure but before balloon dilatation, there was a leak in the indeflator, as noted by continuous bubbles in the device when in the negative setting as well as a hissing sound.The physician decided to still use the indeflator and the balloon was inflated twice; however, it was difficult and required more clockwise turning.The balloon was then removed and the indeflator was replaced to complete the procedure.There were no adverse patient effects and there was no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

H6 medical device problem code 2017- use after damage.The device was returned for analysis.The reported leak was able to be confirmed.The reported noise was not able to be confirmed.Additionally, unused sterile devices were returned and tested with no issues noted.Reportedly, there was a leak in the indeflator, as noted by continuous bubbles in the device when in the negative setting as well as a hissing sound.The physician decided to still use the indeflator and the balloon was inflated twice; however, it was difficult and required more clockwise turning.It should be noted the indeflator 20/30 instruction for use (ifu) states: do not use if the package is open or damaged, or if product is damaged.The deviation of the ifu does not appear to have caused/contributed to the reported difficulties.A review of the lot history record identified one manufacturing nonconformity issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified one similar incident from this lot.The investigation determined the reported difficulties appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.E1.Phone number.

• Brand Name: 20/30 PRIORITY PACK INDEFLATOR
• Type of Device: ACCESSORIES
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11436459
• MDR Text Key: 240311601
• Report Number: 2024168-2021-01800
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08717648013973
• UDI-Public: 08717648013973
• Combination Product (y/n): N
• PMA/PMN Number: K961471
• 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: 05/28/2021

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 Expiration Date: 10/31/2022
• Device Model Number: 1003327
• Device Catalogue Number: 1003327
• Device Lot Number: 60268707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2021
• Initial Date Manufacturer Received: 02/11/2021
• Initial Date FDA Received: 03/08/2021
• Supplement Dates Manufacturer Received: 05/10/2021
• Supplement Dates FDA Received: 05/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1