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

Model Number	1000184
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure was to treat the left anterior descending (lad) coronary artery.The indeflator was connected directly to the balloon and leaked during deflation as seen by the gauge needle pressure decreasing.There were no adverse patient effects and there was no clinically significant delay in the procedure.Another indeflator was used to complete the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection and functional testing analysis was performed on the returned device.The reported leak was not confirmed.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a specific issue.Based on the reported information and the observations from the returned analysis, a definitive cause for the reported leak could not be determined.It was reported that the indeflator was connected directly to the balloon catheter however leaked during inflation, the gauge needle pressure was noted to be decreasing.Factors that may contribute to leak include, but are not limited to, manufacturing, mishandling, damage, loose connections or procedural technique.Analysis of the returned device was unable to confirm the reported leak.In this case, it is possible that the connection port was not fully connected/tightened resulting in the reported leak.There is no indication of a product quality issue with respect to manufacture, design, or labeling; therefore, no product-related corrective action will be implemented in this case.

• 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: 21284877
• Report Number: 2024168-2025-01127
• Device Sequence Number: 9339853
• Product Code: MAV
• UDI-Device Identifier: 08717648013591
• UDI-Public: (01)08717648013591(17)250731(10)60489701
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2025

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: 07/31/2025
• Device Model Number: 1000184
• Device Catalogue Number: 1000184
• Device Lot Number: 60489701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2025
• Supplement Date Received by Manufacturer: 03/10/2025
• Initial Report FDA Received Date: 01/31/2025
• Supplement Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown