• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services


  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

Catalog Number 1012276-30
Device Problems Detachment Of Device Component (1104); Deflation Problem (1149); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)
Patient Problem Foreign Body In Patient (2687)
Event Date 06/28/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). It was reported that the balloon dilatation catheter (bdc) was inflated three times to 20 atmospheres (atm). It should be noted that the trek rx instructions for use (ifu) states: balloon pressure should not exceed the rated burst pressure (rbp). The rbp for the trek rx device is 14 atm; therefore, rbp was exceeded. It was further reported that the balloon had to be removed partially inflated, which likely contributed to the reported difficulty removing the device from the vessel and guiding catheter as resistance was encountered. It was reported that force was applied during the attempt to retract the bdc. It should be noted that 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. Visual and dimensional inspections were performed on the returned device. The separation was confirmed. The difficulty removing the bdc from the vessel and guiding catheter could not be replicated in a testing environment as it was based on operational circumstances. The deflation issue could not be replicated in a testing environment due to the condition of the returned device. 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 investigation was unable to determine a conclusive cause for the reported deflation issues; however, the separation, difficulty removing the device from the vessel and guiding catheter and patient affect appear to be related to circumstances of the procedure. There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. (b)(4). The device was received. Investigation is not yet complete. A follow up report will be submitted with all relevant information.
Event Description
It was reported that on (b)(6) 2017, the procedure was to treat a mildly calcified lesion in the non-tortuous proximal to mid right coronary artery (rca). A 3. 5x30mm trek rx balloon dilatation catheter (bdc) was unpackaged and prepped with 50/50 contrast mix outside of patient anatomy without difficulty. The trek rx was then advanced to the rca and the balloon was inflated three times to 20 atmospheres, successfully completing angioplasty. During the final deflation, negative pressure was applied for 30 seconds to two minutes, but the balloon was unable to be completely deflated (partial deflation was achieved). The bdc was difficult to remove from the vessel and much force was applied to retract the bdc; the bdc was unable to be retracted through the guiding catheter, with force applied. The trek rx, guiding catheter, and guide wire were all withdrawn as a single unit from the anatomy. After withdrawal, it was then noted that the trek rx balloon was torn with a piece of the balloon missing. No attempts were made to retrieve the balloon piece. As the balloon material is not radiopaque, it was unable to be located and, thus, unable to be removed from the anatomy. As of (b)(6) 2017, there have been no adverse patient sequelae. No additional information was provided.
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key6730624
MDR Text Key106769517
Report Number2024168-2017-06080
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 08/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2019
Device Catalogue Number1012276-30
Device Lot Number60525G1
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer07/17/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/17/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2016
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: 07/20/2017 Patient Sequence Number: 1