MAUDE Adverse Event Report: AV-TEMECULA-CT 20/30 PRIORITY PACK W/COPILOT; ACCESSORY KIT

Catalog Number 1003327

Device Problems Break (1069); Leak/Splash (1354); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/13/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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 the procedure was a percutaneous coronary intervention (pci).During indeflator use for inflation, a pop was heard and felt.Following the pop, saline and contrast was noted under the indeflator faceplate and in the dial area.It is unknown if the gauge of the indeflator was reading accurately.An unspecified inflation device was used to successfully continue the procedure.There were no adverse patient effects and no clinically significant delay.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).Evaluation summary: the device was returned for analysis.The reported break/gauge was able to be confirmed.The reported leak and device operates differently than expected/noise were 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 similar incidents from this lot.The investigation determined the difficulties appear to be a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.

• Brand Name: 20/30 PRIORITY PACK W/COPILOT
• Type of Device: ACCESSORY KIT
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8410450
• MDR Text Key: 138542934
• Report Number: 2024168-2019-01916
• Device Sequence Number: 1
• Product Code: MAV
• 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,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/10/2019

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: 11/30/2020
• Device Catalogue Number: 1003327
• Device Lot Number: 60164479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Initial Date Manufacturer Received: 02/15/2019
• Initial Date FDA Received: 03/11/2019
• Supplement Dates Manufacturer Received: 05/29/2019
• Supplement Dates FDA Received: 06/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1