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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT NC TREK CORONARY DILATATION CATHETER

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AV-TEMECULA-CT NC TREK CORONARY DILATATION CATHETER Back to Search Results
Catalog Number 1012445-08
Device Problems Contamination /Decontamination Problem (2895); Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/21/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The device is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the procedure was to treat an unspecified coronary artery. A 2. 0 x 8 mm nc trek balloon dilatation catheter (bdc) was used; however, it could not advance through an unspecified guiding catheter because there was a 2. 5 cm piece of clear plastic noted on the outside of the dilatation catheter towards the middle of the shaft. The foreign material was noted inside the anatomy; therefore, another unspecified device was used to successfully complete the procedure. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Device status changed from returning to not returned. The incident information was reviewed; however, the product was not returned to abbott vascular 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 reported from this lot. The investigation was unable to determine a conclusive cause for the reported difficulty to position through the guiding catheter or foreign material on the device. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
Subsequent to the initial report, additional information was received. It was reported that there was no foreign material left inside the anatomy. No additional information was provided.
 
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Brand NameNC TREK CORONARY DILATATION CATHETER
Type of DeviceCORONARY DILATATION CATHETER
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
MDR Report Key7961048
MDR Text Key123543008
Report Number2024168-2018-07888
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
PMA/PMN Number
K110134
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Remedial Action Other
Type of Report Initial,Followup
Report Date 11/16/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2021
Device Catalogue Number1012445-08
Device Lot Number80602G1
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/08/2018
Is This a Reprocessed and Reused Single-Use Device? No

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