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Catalog Number 1012449-20
Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528)
Patient Problems Stroke/CVA (1770); Death (1802); Unspecified Infection (1930); Coma (2417); Foreign Body In Patient (2687)
Event Date 08/18/2017
Event Type  Death  
Manufacturer Narrative
(b)(4). Evaluation summary: visual and scanning electron microscopy inspection/analysis was performed on the returned device. The reported separation was confirmed. A cine was received and reviewed by an abbott vascular clinical specialist. The reviewer confirmed the dilatation balloon separation proximal to the proximal balloon marker with segment remaining in the anatomy. A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint. Additionally, a review of the complaint history identified no other incidents from this lot. The reported patient effects of death and infection are listed in the coronary dilatation catheters, nc trek rx, instructions for use (ifu)as known patient effects. Also stated in the ifu: balloon pressure should not exceed the rated burst pressure (rbp). The rbp for the nc trek is 18 atmospheres. The investigation determined the reported separation appears to be related to circumstances of the procedure. Additionally, the reported patient effects of cerebrovascular accident, coma, death, foreign body in patient and treatments appear to be related to the separated segment remaining in the anatomy. A conclusive cause for the reported infection and relationship to the device, if any, cannot be determined. There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
Event Description
Subsequent to the previously filed reports, additional information has been received as follows: the nc trek balloon was being used for post-dilatation. There was no resistance felt during advancement of the balloon catheter and no unusual resistance felt during retraction of the device from the patient. The balloon was inflated about 5 times and had been inflated to around 20 atmospheres during use. It was believed that the balloon was fully deflated prior to attempted retraction. The date of the infection was observed was (b)(6) 2017. On or around (b)(6) 2017 is when the stroke, coma and brain death occurred. No additional information was provided.
Manufacturer Narrative
(b)(4). Internal file number - (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 relevant information.
Event Description
It was reported that the procedure was to treat a de novo lesion located in the intensely calcified, moderately tortuous right coronary artery (rca). The 3. 0 x 20 mm nc trek balloon separated from the catheter during attempted removal from the anatomy. An attempt was made to capture the separated portion using a snare device but with no success. The separated segment remains in the anatomy. The patient has since experienced a hemorrhagic stroke, is in a coma, has developed a hospital infection and has suffered brain death and death. The cause of death was due to the change in anticoagulation to compensate for the foreign body in the patient, which resulted in the adverse patient symptoms and subsequent death. No additional information was provided.
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Manufacturer (Section D)
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer (Section G)
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer Contact
connie speck
abbott vascular
26531 ynez road
temecula, CA 92591-4628
MDR Report Key6868753
MDR Text Key105929503
Report Number2024168-2017-07484
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 12/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2020
Device Catalogue Number1012449-20
Device Lot Number70404G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/20/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/30/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/15/2017 Patient Sequence Number: 1