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

Catalog Number 1003327

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number e2019001.The device was not returned for analysis.A review of the lot history record identified one manufacturing nonconformity issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified two 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.The additional indeflator device referenced is being filed under separate medwatch report number.

Event Description

It was reported that the procedure was being performed to treat a mid-right coronary artery.The indeflator would not hold pressure at 12 atmospheres.The unspecified balloon was switched but the same occurred.A new indeflator was then switched but the same occurred.A third indeflator was used successfully.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• 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
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 9531625
• MDR Text Key: 178160750
• Report Number: 2024168-2019-15060
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08717648013973
• UDI-Public: 08717648013973
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K961471
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/30/2019

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: 60164478
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 12/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 77