MAUDE Adverse Event Report: AV-TEMECULA-CT INDEFLATOR PLUS 30 INFLATION DEVICE; ACCESSORIES

Catalog Number	1000183
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.A review of the lot history record revealed no non-conformances that would have contributed to the reported stopcock leak.Further assessment was performed and abbott vascular (av) identified a potential product deficiency related to the manufacture of the device.The issue will be addressed per internal operating procedures.Av will continue to trend the performance of these devices.The additional plus 30 indeflator and the 3 unused/sterile devices referenced are filed under separate medwatch reports.
Event or Problem Description
It was reported that during a percutaneous coronary intervention (pci), two plus 30 indeflators did not maintain pressure when connected to balloon catheters.The devices were replaced with an indeflator from another lot and the procedure was completed without issue.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.Analysis of 3 returned unused/sterile devices noted leaks with the stopcocks.Root cause analysis determined that the issue reported with the indeflators in this case was likely due to a leak in the stopcocks.

• Brand Name: INDEFLATOR PLUS 30 INFLATION DEVICE
• Common Device Name: ACCESSORIES
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6988904
• Report Number: 2024168-2017-08551
• Device Sequence Number: 519216
• Product Code: MAV
• UDI-Device Identifier: 08717648013584
• UDI-Public: 08717648013584
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K896849
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/30/2017

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: 03/31/2018
• Device Catalogue Number: 1000183
• Device Lot Number: 60054443
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2017
• Initial Report FDA Received Date: 10/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1