MAUDE Adverse Event Report: ABBOTT VASCULAR NC TREK RX CORONARY DILATATION CATHETER

Catalog Number	1012455-20
Medical Device Problem Codes	Deflation Problem (1149); Off-Label Use (1494); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: medical device problem code 2017 - contrast incorrect.Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure was to treat the left renal artery with no tortuosity and 60% stenosis.The 5x20 mm nc trek balloon dilatation catheter was inflated once to nominal pressure but only partially deflated.Negative pressure was held for 20 seconds.The balloon had to be ruptured in order to be removed.The contrast mix was 40% contrast, 60% serum.There were no adverse patient sequela.A non-abbott balloon was used to complete the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual, dimensional, and functional inspections were performed on the returned device.The reported deflation issue was confirmed.The reported difficulty removing the device from the guiding catheter 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 similar incidents and/or complaints from this lot.It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global instructions for use (ifu), specified that the contrast is 60% contrast medium diluted 1:1 with normal saline.In this case, since the contrast ratio used was less than the required percentage it is unknown if the ifu violation caused or contributed to the reported complaint.The ifu also states: the nc trek rx coronary dilatation catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with st-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm ¿ 5.00 mm only).In this case, it is unknown if the ifu deviation caused or contributed to the reported complaint.The investigation was unable to determine a conclusive cause for the reported deflation issue; however, the reported difficulty removing the device and unexpected medical intervention appear to be related to circumstances of the procedure.Possible factors that may contribute to difficulty deflating the balloon include, but are not limited to, deflation technique, tortuous anatomy, loose connection with the indeflator, contamination in the inflation lumen or damage to the guide wire and/or inflation lumen.The product risk assessment identifies this as a foreseeable event; as such, design and manufacturing controls and mitigations have been established for potential causes.It was reported that the bdc experienced difficulty being removed from the guiding catheter since the balloon would not completely deflate.Additional treatment by inflating the balloon to rupture was performed in the attempt to remove the device; however, the balloon rupture was not confirmed during return analysis.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.H6: medical device problem codes 1528 and 1494/off label use added.
Event or Problem Description
It was reported that the procedure was to treat the left renal artery with no tortuosity and 60% stenosis.The 5x20 mm nc trek balloon dilatation catheter was inflated once to nominal pressure but only partially deflated.Negative pressure was held for 20 seconds.The balloon had to be ruptured in order to be removed.The contrast mix was 40% contrast, 60% serum.There were no adverse patient sequela.A non-abbott balloon was used to complete the procedure.Subsequent to the initially filed report, it was reported that the serum in the contrast mix is saline and there was resistance with the guiding catheter during removal.No additional information was provided.

• Brand Name: NC TREK RX CORONARY DILATATION CATHETER
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR COSTA RICA, REG # 3009564766; 52 calle 3 b31 coyol free zone; el coyol alajuela ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 18219427
• Report Number: 2024168-2023-13123
• Device Sequence Number: 5672098
• Product Code: LOX
• UDI-Device Identifier: 08717648152160
• UDI-Public: 08717648152160
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K103153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2025
• Device Catalogue Number: 1012455-20
• Device Lot Number: 20813G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/08/2024
• Initial Report FDA Received Date: 11/28/2023
• Supplement Report FDA Received Date: 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male