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

Model Number 1003327

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371); Product Quality Problem (1506)

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

Event Date 01/12/2022

Event Type  malfunction  

Event Description

It was reported that the indeflators can occasionally be slow to inflate balloons and it takes multiple turns of the handle to pressurize.This issue occurs intermittently and not on every device.Occasionally the connection between the indeflator and the balloon slips and comes disconnected when the indeflator is being pressurized.This only seems to occur when the indeflator is connected directly to the balloon, and not when the indeflator is connected to a 3-way stopcock.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Date of event - estimated.The device was not returned for analysis.A review of the lot history record and similar incident review 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 loose connection and 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.

Manufacturer Narrative

Date of event - estimated.The device was not returned for analysis.A review of the lot history record and similar incident review 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 loose connection and 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.

Event Description

It was reported that the indeflators can occasionally be slow to inflate balloons and it takes multiple turns of the handle to pressurize.This issue occurs intermittently and not on every device.Occasionally the connection between the indeflator and the balloon slips and comes disconnected when the indeflator is being pressurized.This only seems to occur when the indeflator is connected directly to the balloon, and not when the indeflator is connected to a 3-way stopcock.There were no adverse patient effects and no clinically significant delay in 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 could not be conducted because the lot number was not provided.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.The product associated with this complaint is potentially from the impacted population as the lot number is unknown.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.H6: investigation findings code 213 - removed.H6: investigation conclusions code 67 - removed.H10: narrative - revised.

Manufacturer Narrative

H6: code correction onlyh6 medical device problem code 1354 - removed h10: narrative - revised.

• 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: 13416212
• MDR Text Key: 286134289
• Report Number: 2024168-2022-01056
• 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,Followup
• Report Date: 04/08/2022

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 Model Number: 1003327
• Device Catalogue Number: 1003327
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2022
• Initial Date FDA Received: 02/01/2022
• Supplement Dates Manufacturer Received: 02/25/2022; 03/24/2022
• Supplement Dates FDA Received: 03/21/2022; 04/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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