MAUDE Adverse Event Report: ABBOTT VASCULAR INC. INDEFLATOR; ACCESSORIES

Model Number	1003327
Medical Device Problem Codes	Leak/Splash (1354); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A sterile indeflator device was returned.During functional testing of the indeflator, resistance was felt when pulling the handle.There was a sound of rod sliding through the half nuts when the handle was being pulled back and forth.The device failed at vacuum test.The device was not used in a procedure and there was no patient involvement.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The leak was able to be confirmed.The physical resistance / sticking was able to be confirmed.Production record and corrective and preventive actions (capa) reviews were performed and revealed an indication of a product quality issue.Additionally, a review of the complaint handling database identified similar incidents from this lot.The investigation determined the reported difficulties appear to be a potential product quality issue.On oct 24th 2024, abbott vascular determined that a field action was required for specific lots of ppak 20/30 w/copilot product.The product associated with this complaint is from the impacted population.This action is being taken due to an increased potential for a leak in the indeflator under pressure or vacuum due to a gap in the hose snap fitting and o-rings from a specific supplier.B3: date of event estimated.

• Brand Name: INDEFLATOR
• Common Device Name: ACCESSORIES
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• 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: 20689064
• Report Number: 2024168-2024-13473
• Device Sequence Number: 20640475
• Product Code: MAV
• UDI-Device Identifier: 08717648013973
• UDI-Public: (01)08717648013973(17)260430(10)60561753
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K991102
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 11/14/2024

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: 04/30/2026
• Device Model Number: 1003327
• Device Catalogue Number: 1003327
• Device Lot Number: 60561753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2024
• 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