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	07/07/2017
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.The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.
Event or Problem Description
It was reported that the procedure was to perform angioplasty in the lesion of an unspecified vessel with an unspecified balloon catheter.An indeflator plus 30 inflation device was prepped, with one end of the provided 3-way stopcock successfully connected to the indeflator and the other end of the 3-way stopcock successfully connected to the unspecified balloon hub without any issues.When inflating the indeflator to 8 atmospheres (atm), a leak occurred just under the white rotating handle of the 3-way stopcock.Another indeflator plus 30 with another 3-way stopcock from the same lot was used successfully to complete the procedure.There were no adverse patient effects and no occurrence of a clinically significant delay.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Evaluation summary: the device was returned for evaluation and abbott vascular (av) confirmed the reported stopcock leak.A review of the lot history record revealed no non-conformance's that would have contributed to the reported event.Further assessment was performed and 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.
Event or Problem Description
Subsequent to the initial filed medwatch report, the following additional information was received: the indeflator was prepped per standard procedure; the indeflator was connected to the straight port, a syringe was connected to the side port, and negative pressure was pulled.The leak as noted when the indeflator was pressurized with a starting pressure of approximately 6 atmospheres.No additional information was provided.

• 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: 6757760
• Report Number: 2024168-2017-06312
• Device Sequence Number: 1853136
• Product Code: MAV
• UDI-Device Identifier: 08717648013584
• UDI-Public: 08717648013584
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K896849
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• 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?: Yes
• Date Returned to Manufacturer: 07/13/2017
• Initial Date Received by Manufacturer: 07/07/2017
• Supplement Date Received by Manufacturer: 10/23/2017
• Initial Report FDA Received Date: 08/01/2017
• Supplement 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
• Patient Age: 68 YR