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

Model Number 1003327

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6) 2019 is an estimated date of event.Exemption number e2019001.The customer reported the device was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was performed to treat an unspecified lesion.The 3-way stopcock did not rotate properly to obtain a secure connection with an unspecified non-abbott balloon.The 3-way stopcock was replaced by another not abbott device.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.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 incidents from this lot.As the device was not returned for analysis, the investigation determined a conclusive cause for the reported difficulties cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 9512855
• MDR Text Key: 178175747
• Report Number: 2024168-2019-14946
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 01/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: 1003327
• Device Catalogue Number: 1003327
• Device Lot Number: 60191909
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/04/2019
• Initial Date FDA Received: 12/23/2019
• Supplement Dates Manufacturer Received: 01/06/2020
• Supplement Dates FDA Received: 01/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1