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

Catalog Number	1000184
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a moderately calcified, moderately tortuous left anterior descending artery.The 20/30 indeflator was noted to have a water leak from within the pressure gauge when attempting to inflate a 2.75x15mm non-abbott balloon.A new 20/30 indeflator was used to inflate same balloon successfully.A 3.5x32mm non-abbott stent was implanted and post dilatated with 3.5x15mm balloon.There was no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.Device history record (dhr) and corrective and preventive 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 lot level product quality issue.As the device was not returned for analysis the investigation was unable to determine a conclusive cause for the reported leak difficulties.Based on the reported information and results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: 20/30 PRIORITY PACK INDEFLATOR
• 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: 19157656
• Report Number: 2024168-2024-04957
• Device Sequence Number: 17993677
• Product Code: MAV
• UDI-Device Identifier: 08717648013591
• UDI-Public: (01)08717648013591(17)250731(10)60488528
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/22/2024

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: 07/31/2025
• Device Catalogue Number: 1000184
• Device Lot Number: 60488528
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2024
• Initial Report FDA Received Date: 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 2.75X15MM EUPHORA BALLOON
• Patient Sex: Unknown