MAUDE Adverse Event Report: ABBOTT VASCULAR INC. NC TREK; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	1012452-15
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Improper or Incorrect Procedure or Method (2017); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.B3: date of event is estimated as (b)(6) 2024.H6: medical device problem code 2017 clarifier- incorrect removal.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the left anterior descending artery.Reportedly a 3.75x15mm nc trek rx balloon dilatation catheter (bdc) was inflated to 12-14 atmospheres; however, the balloon was unable to be deflated.Resistance was noted during the removal and the bdc was unable to be removed through the 6f guiding catheter (gc).The balloon was noted to have ruptured within the shaft of the gc.The device was removed, and another nc trek was used to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the left anterior descending artery.Reportedly a 3.75x15mm nc trek rx balloon dilatation catheter (bdc) was inflated to 12-14 atmospheres; however, the balloon was unable to be deflated.Resistance was noted during the removal and the bdc was unable to be removed through the 6f guiding catheter (gc).The balloon was noted to have ruptured within the shaft of the gc.The device was removed, and another nc trek was used to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.Subsequent to the initially filed report, the device return analysis revealed that the inner and outer member of the shaft were separated, and the proximal portion was not returned.These damages were unable to be confirmed by the account.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection and functional testing were performed on the returned device.The reported balloon rupture was confirmed.The reported failure to deflate and difficulty removing the device could not be replicated in a testing environment due to the condition of the returned device.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no other similar complaints from this lot.Based on the reported information and the observations from the returned device analysis, a definitive cause for the reported failure to deflate could not be determined; however, the reported balloon rupture and difficulty removing the device appear to be related to circumstances of the procedure.Possible factors that may contribute to failure to deflate the balloon include, but are not limited to, deflation technique, loose connection with the indeflator, contrast concentration, contamination in the inflation lumen or damage to the guide wire and/or inflation lumen.It was reported by the account that the balloon ruptured during removal from the guiding catheter as difficulty was experienced.It is likely that the balloon material became caught on the guiding catheter as the balloon could not deflate, resulting in the reported balloon rupture and subsequently the ruptured balloon material became caught on the guiding catheter, resulting in the reported difficulty removing the device and noted shaft separation.Based on the results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Correction: h6 medical device problem code 2017 was removed.

• Brand Name: NC TREK
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• 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: 20125776
• Report Number: 2024168-2024-10351
• Device Sequence Number: 7417773
• Product Code: LOX
• UDI-Device Identifier: 08717648152030
• UDI-Public: (01)08717648152030(17)270131(10)40227G1
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K110134
• 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): 11/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1012452-15
• Device Catalogue Number: 1012452-15
• Device Lot Number: 40227G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2024
• Supplement Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2024
• 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
• Patient Sex: Unknown