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

Catalog Number 1003327

Device Problems Material Separation (1562); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/13/2019

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 was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the 20/30 indeflator was being used to inflate an unspecified balloon catheter; however, the gauge separated around 20 atmospheres and made a "paw" sound.The procedure was successfully completed with a new 20/30 indeflator.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Internal file number: (b)(4).Evaluation summary: the device was returned for analysis.The reported detachment of device component was able to be confirmed.The reported device operates differently than expected/noise was unable to be replicated in a testing environment due to the condition of the returned device.The indeflator was sent to scanning electron microscopy for further analysis.The results noted the tabs on the complaint device were documented and compared to the tabs on the damaged and good proxy devices.The tabs on the complaint and damaged proxy device appeared bent.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 leak appears 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: 8666973
• MDR Text Key: 146937602
• Report Number: 2024168-2019-04355
• 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,distri
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/20/2019

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: 01/31/2021
• Device Catalogue Number: 1003327
• Device Lot Number: 60173793
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/28/2019
• Initial Date Manufacturer Received: 05/13/2019
• Initial Date FDA Received: 06/04/2019
• Supplement Dates Manufacturer Received: 07/31/2019
• Supplement Dates FDA Received: 08/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1