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Catalog Number 1012455-15
Device Problems Deflation Problem (1149); Leak/Splash (1354); Difficult to Remove (1528); Material Rupture (1546); Improper or Incorrect Procedure or Method (2017); Material Split, Cut or Torn (4008)
Patient Problems Bradycardia (1751); Non specific EKG/ECG Changes (1817); Low Blood Pressure/ Hypotension (1914)
Event Date 01/31/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The device has been retained by the account. Investigation is not yet complete. A follow up will be submitted with additional information.
Event Description
It was reported that this was a percutaneous intervention treating an ostial right coronary artery (rca) lesion. An nc trek dilatation catheter advanced without issue and post-dilatation was successfully performed 3-4 times. Following the last dilatation, the balloon was unable to deflate. Multiple wires and a cutting balloon were used to pop the balloon, without success. The patient started becoming hypotensive and bradycardic. St elevation was also noted. A clinically significant delay had occurred and, without any success popping the balloon, the physician then forcefully yanked to remove the device. Difficulty removing the nc trek was noted with both anatomy and at the sheath as the balloon was still inflated. Once in the sheath, the balloon either deflated or popped, it could not be confirmed which, and all was removed from the patient. Once outside the anatomy, a hole with leaking was observed in the catheter shaft. Medications were provided and the patient stabilized. The patient was transferred to intensive care for observation. No additional information was provided regarding this issue.
Manufacturer Narrative
(b)(4). The device was not returned for evaluation. 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. The reported patient effect of hypotension as listed in the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use (ifu) is a known patient effect. Additionally, the ifu states: if resistance is felt, determine the cause before proceeding. Continuing to advance or retract the catheter while under resistance may result in damage to the vessels and / or damage / separation of the catheter. It is likely that the use of force contributed to the reported balloon rupture, torn material and subsequently to the leak. The investigation was unable to determine a conclusive cause for the reported deflation issue; however, the reported leak, difficulty removing the device from the anatomy and introducer sheath, balloon rupture, torn material and additional treatment, appear to be related to circumstances of the procedure. A conclusive cause for the reported bradycardia, st elevation and hypotension and the 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 initial 30-day medwatch report, a user facility medwatch (mw5084259) was received stating: patient undergoing cardiac catheterization. Cardiologist attempted to deflate non-compliant balloon (5. 0x12) and balloon would not deflate. New indeflator was used to deflate without success. Respiratory care and medflight put on standby due to emergent case. Rep for abbott notified urgently asking for advice/solutions without success. Patient remained stable during process. Cardiologist had to inflate balloon further to rupture it. Although above states 5. 0x12, the part and lot number match the 5. 0x15mm part and lot number as reported on the initial 30-day medwatch report.
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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 Key8350215
MDR Text Key136490383
Report Number2024168-2019-01202
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 03/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2021
Device Catalogue Number1012455-15
Device Lot Number81112G1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/19/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2018
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: 02/19/2019 Patient Sequence Number: 1