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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. ATTAIN SELECT; CATHETER, PERCUTANEOUS
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MEDTRONIC, INC. ATTAIN SELECT; CATHETER, PERCUTANEOUS Back to Search Results
Model Number 6238TEL
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Vascular Dissection (3160)
Date of Event 10/05/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that during an implant procedure during coronary sinus (cs) cannulation, the patient experienced a dissection of the cs.The patient was a participant in the (b)(6) study.No further patient complications have been reported as a result of this event.
 
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Brand Name
ATTAIN SELECT
Common Device Name
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
MDR Report Key7094353
Report Number2182208-2017-02124
Device Sequence Number16509223
Product Code DQY
UDI-Device Identifier00885074058702
UDI-Public00885074058702
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K042194
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/07/2017
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? No
Operator of Device Health Professional
Device Expiration Date07/10/2019
Device Model Number6238TEL
Device Catalogue Number6238TEL
Device Lot Number00125071
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/05/2017
Initial Report FDA Received Date12/07/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Age84 YR
Patient Weight64
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