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

Model Number	1000186
Medical Device Problem Codes	Leak/Splash (1354); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a fistula in an unspecified artery.A non-abbott drug-eluting balloon was advanced in the patient and the indeflator was connected to the balloon.The physician wanted to perform a long inflation at 10 atmospheres (atms); however, the indeflator would not hold pressure at 10 atms.Additionally, a slow leak was observed at the connection.Another indeflator was used to complete the procedure.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
A visual and functional inspection was performed on the returned device.The reported leaks and intermittent connection were unable to be confirmed.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.A review of the complaint history revealed no other similar incidents.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.

• Brand Name: 20/30 PRIORITY PACK ACCESSORY KIT
• Common Device Name: 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: 13579339
• Report Number: 2024168-2022-01862
• Device Sequence Number: 4368523
• Product Code: MAV
• UDI-Device Identifier: 08717648013614
• UDI-Public: 08717648013614
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K961471
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 1000186
• Device Catalogue Number: 1000186
• Device Lot Number: 60320909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2022
• Supplement Date Received by Manufacturer: 02/25/2022; 03/20/2022
• Initial Report FDA Received Date: 02/22/2022
• Supplement Report FDA Received Date: 03/20/2022; 04/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: UNK
• Patient Sequence Number: 1
• Patient Sex: Unknown