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

Model Number 1003327

Device Problem Leak/Splash (1354)

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

Event Date 12/02/2021

Event Type  malfunction  

Event Description

It was reported this was a procedure to treat an unspecified lesion.When attempting to pull negative, air would enter the chamber of the indeflator.The indeflator was replaced and the procedure was successfully performed.There were no adverse patient effects and no clinically significant delay during the procedure.No additional information was provided.

Manufacturer Narrative

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 lot number was not provided.It is possible that the device was not fully connected resulting in the reported leak; however, as the device was not returned for analysis, this cannot be confirmed.The investigation was unable to determine a conclusive cause for the reported difficulties.There is no indication of a product quality issue with respect to design, manufacture or labeling.Date of event is estimated as (b)(6) 2021.

Manufacturer Narrative

The device was returned for analysis.The reported leak was unable to be confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot specific quality issue.As the reported leak was unable to be confirmed during return analysis, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that the device was not fully connected resulting in the reported leak.There is no indication of a product quality issue with respect to design, manufacture or labeling.D4: lot #, expiration date added.D9: device available.H4: device manufacture date added.H6: type of investigation code 4115 removed; type of investigation codes 10, 4109, 3331 added.H6: investigation finding code 213 removed; investigation finding code 114 added.H6: investigation conclusion code 67 removed; investigation conclusion code 4311 added.

Manufacturer Narrative

The device was returned for analysis.The reported leak was unable to be confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.One nonconforming material record/exception was generated for the finished good lot to investigate the reported issue in accordance with internal operating procedures.A review of the complaint history revealed one other similar incident.The investigation determined the reported difficulties appear to be a potential product quality issue.On feb 25th, 2022 abbott vascular decided to initiate a voluntary field action for this product.Abbott vascular submitted medwatch # 2024168-2022-01831 on march 4, 2022 with notification of the voluntary recall in h7, (remedial action initiated).Corrective action has been initiated per site operating procedures.Field safety corrective action is required for specific lots of 20/30 and plus 30 indeflators and associated priority packs: 20/30 priority pack with copilot, 20/30 priority pack, priority pack 20/30 w/115 rhv, ppak 20/30 with rhv, plus 30, ppakplus30, ppakplus30 w/115 rhv.The product will continue to be trended.This action is being taken due to an increase in the complaint trend for reported leak/splash and loose or intermittent connection.20/30 indeflators are at an increased risk of leaking due to a gap in the hose snap fitting.Stopcocks are at an increased risk of leaking due to a higher tendency for loose connections when not connected properly.H6: investigation findings code 114 removed, investigation conclusions code 4311 removed.

• 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: 13087934
• MDR Text Key: 286859817
• Report Number: 2024168-2021-12162
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08717648013973
• UDI-Public: 08717648013973
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 03/21/2022

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: 08/31/2023
• Device Model Number: 1003327
• Device Catalogue Number: 1003327
• Device Lot Number: 60320072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2021
• Initial Date FDA Received: 12/27/2021
• Supplement Dates Manufacturer Received: 01/25/2022; 02/25/2022
• Supplement Dates FDA Received: 01/27/2022; 03/21/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/10/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: UNK
• Patient Sequence Number: 1