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

Model Number 1003327

Device Problems Leak/Splash (1354); Product Quality Problem (1506)

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

Event Date 05/03/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Event Description

It was reported that the procedure was to treat a lesion in the right coronary artery with mild calcification.The indeflator was used in the procedure to inflate a trek balloon, nc trek balloons and a xience stent; however, it was noted inflation of the devices took longer than expected to achieve the required atmospheres.It was n noted that when using the indeflator, the inflation device had to be rotated many times to inflate the balloons and inflation device was not able to maintain negative when deflating the balloons.Although a leak was not detected, possibly the three-way stopcock was not allowing the indeflator to hold negative pressure.A non-abbott inflation device was used to continue the procedure.There was no adverse patient effect and no clinically significant delay reported in the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported leak and the reported product quality problem (device had to be rotated many times to inflate the balloons and inflation device was not able to maintain negative when deflating the balloons) were unable to be confirmed; however a potential product quality issue appears to be related to the reported lot.A review of the lot history record identified one manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified one other similar incident from this lot.The investigation determined the reported difficulties appear to be a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular (av) will continue to trend the performance of these devices.

• 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: 16980149
• MDR Text Key: 315926941
• Report Number: 2024168-2023-05457
• Device Sequence Number: 1
• Product Code: MAV
• Combination Product (y/n): N
• PMA/PMN Number: K961471
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/07/2023

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 Expiration Date: 01/31/2024
• Device Model Number: 1003327
• Device Catalogue Number: 1003327
• Device Lot Number: 60408856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/03/2023
• Initial Date FDA Received: 05/22/2023
• Supplement Dates Manufacturer Received: 06/14/2023
• Supplement Dates FDA Received: 07/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2022
• 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