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	07/08/2024
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 during the procedure, a 20/30 priority pack indeflator was connected directly to a balloon hub and did not hold pressure when inflating.Another unspecified indeflator was used.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported leak was unable to be replicated in a testing environment due to the condition of the returned device (needle was at the ¿vac¿ position).Device history record (dhr) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint handling database identified no other similar incidents from this lot.It is possible that the connection port was not fully connected/tightened and/or the device being connected was compromised thus resulting in the reported leak difficulties; however this cannot be confirmed.Additionally, inadvertent mishandling during use and/or during shipment for return analysis possibly resulted in the noted needle at the ¿vac¿ position; however this cannot be confirmed.The investigation was unable to determine a conclusive cause for the reported/noted 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.
Additional Manufacturer Narrative
The device was returned for analysis.The reported leak was unable to be replicated in a testing environment due to the condition of the returned device (needle was at the ¿vac¿ position).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 indeflator 20/30 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.

• 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: 19896897
• Report Number: 2024168-2024-09167
• Device Sequence Number: 12480043
• Product Code: MAV
• UDI-Device Identifier: 08717648013591
• UDI-Public: (01)08717648013591(17)241130(10)60418466
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• 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: 11/30/2024
• Device Model Number: 1000184
• Device Catalogue Number: 1000184
• Device Lot Number: 60418466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/11/2024
• Supplement Date Received by Manufacturer: 09/04/2024; 10/24/2024
• Initial Report FDA Received Date: 08/02/2024
• Supplement Report FDA Received Date: 09/25/2024; 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2022
• 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