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

Catalog Number 1003327

Device Problems Leak/Splash (1354); Product Quality Problem (1506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/26/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).There may be gaps in numbering for reports submitted during the transition period.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 during a coronary procedure, an indeflator was being used with an unspecified balloon catheter for pre-dilatation.The balloon of the balloon catheter failed to inflate and contrast was noted to pass into the indeflator body [face plate].A new indeflator was used; however, the same issue occurred.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Exemption number e2019001 permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device was returned for analysis.The reported leak and irregular appearance were unable to be confirmed as the device performed as intended.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 one other similar incident from this lot.The investigation determined the reported difficulties appears to be related to 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 20/30 INDEFLATOR
• Type of Device: ACCESSORIES
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8971090
• MDR Text Key: 156795813
• Report Number: 2024168-2019-11543
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08717648013973
• UDI-Public: 08717648013973
• 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: 10/31/2019

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: 12/31/2020
• Device Catalogue Number: 1003327
• Device Lot Number: 60166462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Initial Date Manufacturer Received: 08/15/2019
• Initial Date FDA Received: 09/06/2019
• Supplement Dates Manufacturer Received: 10/22/2019
• Supplement Dates FDA Received: 10/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1