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

Model Number 1000186

Device Problems Break (1069); Leak/Splash (1354); Loose or Intermittent Connection (1371); Material Separation (1562)

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

Event Date 01/21/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event estimated.The device was discarded and will not be returned for evaluation.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that during use of the copilot device, cracks, leaks, and/or unstable connection at the gray stopcock port were observed during inflation attempts.There were no adverse patient effects reported.No additional information was provided.

Event Description

Subsequent to the initial medwatch report, it was stated that material separation was possible.

Manufacturer Narrative

The device was not returned for analysis however 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.Additionally, a review of the complaint history revealed 8 other incidents.The investigation determined the reported difficulties appear to be a potential product quality issue.On (b)(6) 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 copliot, 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.Na.

• Brand Name: 20/30 PRIORITY PACK ACCESSORY KIT
• 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: 13564522
• MDR Text Key: 286384577
• Report Number: 2024168-2022-01746
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08717648013614
• UDI-Public: 08717648013614
• 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
• Type of Report: Initial,Followup
• Report Date: 03/20/2022

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: 09/30/2023
• Device Model Number: 1000186
• Device Catalogue Number: 1000186
• Device Lot Number: 60326623
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2022
• Initial Date FDA Received: 02/18/2022
• Supplement Dates Manufacturer Received: 02/25/2022
• Supplement Dates FDA Received: 03/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2021
• 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