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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR 20/30 PRIORITY PACK INDEFLATOR; ACCESSORIES Back to Search Results
Model Number 1003327
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/22/2020
Event Type  malfunction  
Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The other two devices referenced are filed under separate medwatch report numbers.
 
Event Description
It was reported that the procedure was to treat a chronic total occlusion (cto) patient and lesion located in the right coronary artery.The lesion was a mid to distal long cto lesion.The junction where the copilot screws on to the guide catheter kept unscrewing and would not connect.This happened three times.A new copilot was used to continue the procedure.There were no reported adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
 
Manufacturer Narrative
The device was returned for analysis.The reported loose or intermittent connection was unable to be confirmed.The returned guiding catheter was connected to the copilot bleedback control valve (bbcv) rotator, forming a secure connection.There were no anomalies noted to the connections as reported.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 reported loose or intermittent connection was unable to be confirmed during return analysis, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that a buildup of procedural contaminants (blood, contrast) on the device and/or the device was not completely connected/fully tightened thus resulted in the reported loose connection.There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
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Brand Name
20/30 PRIORITY PACK INDEFLATOR
Type of Device
ACCESSORIES
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
MDR Report Key11152844
MDR Text Key226315231
Report Number2024168-2021-00330
Device Sequence Number1
Product Code MAV
UDI-Device Identifier08717648013973
UDI-Public08717648013973
Combination Product (y/n)N
PMA/PMN Number
K961471
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 02/05/2021
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 Date08/31/2022
Device Model Number1003327
Device Catalogue Number1003327
Device Lot Number60259848
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/30/2020
Initial Date Manufacturer Received 12/22/2020
Initial Date FDA Received01/11/2021
Supplement Dates Manufacturer Received01/27/2021
Supplement Dates FDA Received02/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
LAUNCHER GUIDE CATHETER; LAUNCHER GUIDE CATHETER
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