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

Catalog Number 1012454-15

Device Problems Deflation Problem (1149); Difficult to Remove (1528)

Patient Problem Ischemia (1942)

Event Date 10/06/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. Patients weight estimated. The device was not returned 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 incidents from this lot. Ischemia is a known secondary effect of additional therapy/non-surgical treatment. The investigation was unable to determine a conclusive cause for the reported deflation difficulty with subsequent removal difficulty. Based on the case information and related record review, a conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined; however the treatment appears to be related to the operational context of the procedure. Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that during a percutaneous coronary intervention procedure to treat a 90% stenosed, eccentric, de novo lesion in the ectatic proximal right coronary artery (rca) via radial access, pre-dilatation was performed using an unspecified 3. 0x15 balloon then a 4. 0x28 xience drug-eluting stent was successfully deployed. A 4. 5x15 nc trek rx balloon dilatation catheter (bdc) was unpackaged without issue then advanced without resistance into a non-abbott guiding catheter and post-dilatation was performed. The balloon was successfully inflated then deflated once. The balloon was inflated a 2nd time when the patient experienced ischemia necessitating prompt balloon removal and disengagement of the guide catheter. When attempting to deflate the nc trek rx balloon, it only partially deflated. The partially deflated balloon was pulled back to the guide catheter, but was unable to be withdrawn into the guide catheter, causing the guide catheter to disengage. The balloon was then inflated inside of the aorta, then deflation was attempted there; the balloon would not deflate. Using ultrasound guidance, a snare was then advanced via femoral access to pull the inflated balloon to the tip of the engaged 8fr femoral sheath where a non-abbott probe (spinal) needle was used to puncture the nc trek rx balloon. The deflated nc trek rx balloon was then removed through the femoral sheath intact, with no residual balloon material remaining inside of the patient. The ischemia self-resolved upon deflation and withdrawal of the 4. 5x15 nc trek rx from the anatomy. The resulting lesion stenosis was 10%. There were no adverse patient sequelae and no occurrence of a clinically significant delay. No additional information was provided.

• Brand Name: NC TREK CORONARY DILATATION CATHETER
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): EL COYOL, COSTA RICA REG# 3009031392; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 6062448
• MDR Text Key: 58600297
• Report Number: 2024168-2016-07359
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K110134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 1012454-15
• Device Lot Number: 60329G1
• 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 Received: 10/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2016
• 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: 10/27/2016 Patient Sequence Number: 1

Treatment

GUIDING CATHETER: JR4STENT: 4.0X28 XIENCE