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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR COPILOT; ACCESSORIES

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ABBOTT VASCULAR COPILOT; ACCESSORIES Back to Search Results
Catalog Number 1003330
Device Problems Difficult to Insert (1316); Product Quality Problem (1506)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/31/2019
Event Type  Injury  
Manufacturer Narrative
G9: 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 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 similar incidents from this lot.The investigation determined the reported difficulties appears to be related to circumstances of the procedure as it is likely that the cap seal was not entirely opened; thus resulting in the reported difficulty to insert and the reported irregular appearance (inlet of y-valve was narrow).The reported delayed therapy/non-surgical treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
It was reported that the patient presented with a myocardial infarction and the procedure was performed to treat a lesion in the left anterior descending coronary artery with moderate calcification.An unspecified guide wire was inserted through a copilot bleed back control valve without issue.On attempting to advance an unspecified balloon catheter through the copilot, resistance was met and the inlet of the copilot was noted to be narrow.A new copilot bleed back control valve was used to successfully continue the procedure; however, the event prolonged the operation time and radiation exposure to the patient.The final patient outcome was reported to be satisfactory.No additional information was provided.
 
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Brand Name
COPILOT
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 rd.
temecula CA 92591 4628
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key8942550
MDR Text Key156015177
Report Number2024168-2019-11309
Device Sequence Number1
Product Code DTL
UDI-Device Identifier08717648013980
UDI-Public08717648013980
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K991102
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Physician
Type of Report Initial
Report Date 08/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2021
Device Catalogue Number1003330
Device Lot Number60172094
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/09/2019
Initial Date FDA Received08/28/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/26/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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