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

Model Number 1003327

Device Problems Leak/Splash (1354); Physical Resistance/Sticking (4012)

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

Event Date 10/31/2021

Event Type  malfunction  

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.On (b)(6) 2022 abbott vascular decided to initiate a voluntary field action for this product.Corrective action has been initiated per site operating procedures.On (b)(6) 2022, abbott vascular notified a foreign competent authority of a field safety corrective action 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.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.The additional device referenced is filed under a separate medwatch report number.

Event Description

It was reported that during preparation of the indeflator, there was resistance when turning/pulling the handle and it could not be turned to negative.The device was noted to have minimal bubbles in the tube but not the housing.There was no device use or patient involvement.Another indeflator was used to complete the procedure.There was no clinically significant delay in the procedure.No additional information was provided.Returned device analysis identified the indeflator did not hold pressure; a leak was observed at the connection between the distal end of the rotator and the proximal end of the luer lock and was returned with visible blood on the handle and on the syringe housing indicating possible use during the procedure.A used indeflator was received with the same reported issue.

Manufacturer Narrative

A visual and functional inspection was performed on the returned device.The reported leak and sticking of the handle were unable to be confirmed.Additionally, this complaint appears to be related to a manufacturing issue associated with leak issues.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 1 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.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.B5: the following statement was removed: returned device analysis identified the indeflator did not hold pressure; a leak was observed at the connection between the distal end of the rotator and the proximal end of the luer lock and was returned with visible blood on the handle and on the syringe housing indicating possible use during the procedure.

• 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: 13832200
• MDR Text Key: 289505349
• Report Number: 2024168-2022-02886
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08717648013973
• UDI-Public: 08717648013973
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/11/2022

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: 07/31/2023
• Device Model Number: 1003327
• Device Catalogue Number: 1003327
• Device Lot Number: 60315919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/25/2022
• Initial Date FDA Received: 03/20/2022
• Supplement Dates Manufacturer Received: 03/20/2022
• Supplement Dates FDA Received: 04/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2021
• 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