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

Model Number 1000184

Device Problem Leak/Splash (1354)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 11/28/2019

Event Type  malfunction  

Manufacturer Narrative

Event date estimated.Exemption number e2019001.The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that at the extension connection of the indeflator, contrast suction was not possible.There were no reported adverse patient effects and there was no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported leak/contrast suction issue was unable to be confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents from this lot.As the reported leak/contrast suction issue was unable to be confirmed during return analysis, it is possible that the indeflator was not fully connected resulting in the reported difficulties (contrast suction not possible); however this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design or labeling.B3: date of event h6: patient code (b)(6) was removed.

Event Description

Additional information provided indicating that the issue occurred during preparation of the device.There was no patient involvement.A new indeflator of the same lot was used to continue the procedure.No additional information was provided.

• Brand Name: INDEFLATOR PPAK 20/30
• Type of Device: ACCESSORIES
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9513685
• MDR Text Key: 178174388
• Report Number: 2024168-2019-14961
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08717648013591
• UDI-Public: 08717648013591
• Combination Product (y/n): N
• PMA/PMN Number: K961471
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 05/22/2020

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 Expiration Date: 03/31/2021
• Device Model Number: 1000184
• Device Catalogue Number: 1000184
• Device Lot Number: 60179607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2020
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 12/23/2019
• Supplement Dates Manufacturer Received: 05/01/2020
• Supplement Dates FDA Received: 05/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1