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

Model Number	1012448-20
Medical Device Problem Codes	Leak/Splash (1354); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the 2.75x20 mm nc trek balloon dilatation catheter (bdc) was noted to have ruptured at nominal pressure, as when pressure was increased, the contrast went into the artery.There were no adverse patient effects and there was no clinically significant delay in the procedure.A new similar balloon was used to complete the procedure.No additional information was provided.
Additional Manufacturer Narrative
B3: date of event has been estimated.Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
D9, h3: device returning status updated from yes to not returning.The device was not returned for evaluation.The electronic lot history record (elhr) and corrective and preventive 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.Possible factors that could contribute to balloon material ruptures include, but are not limited to, balloon damage during processing of the balloon material, inflation technique, interactions with other devices, lesion calcification or a previously implanted stent.Based on the reported information and results of the complaint investigation, there is no indication that the reported balloon rupture is related to a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the 2.75x20 mm nc trek balloon dilatation catheter (bdc) was noted to have ruptured at nominal pressure, as when pressure was increased, the contrast went into the artery.There were no adverse patient effects and there was no clinically significant delay in the procedure.A new similar balloon was used to complete the procedure.Subsequent to the initially filed report, it was reported that the procedure was to treat the descending coronary artery with no calcification.No additional information was provided.
Additional Manufacturer Narrative
Visual, functional and sem analysis were performed on the returned device.The reported leak was confirmed.The production record review was performed and revealed no indication of a product quality issue.The preventive actions (capa) review was performed and revealed a capa issue related to the reported issue; indicating there is a potential product quality issue.Additionally, a review of the complaint history identified no other similar complaints from this lot.The balloon was ultimately sent to the scanning electron microscopy (sem) lab for further analysis.The sem report determined the joint failure may be attributed to exposure conditions and/or a materials/processing discrepancy initiating along the bond area.The leak exhibited thinned, stretched, and torn material.The investigation determined a potential product quality issue based on the evaluation of the returned unit and the review of the corrective and preventive actions (capa) database.The leak was found in the shaft in the guide wire notch area.It was determined the joint failure may be attributed to exposure conditions and/or a materials/processing discrepancy initiating along the bond area.The leak exhibited thinned, stretched, and torn material.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.H6 - reported medical device problem code 1546 was removed and 1354 added.H6 - type of investigation code 4114 removed; 10 added.H6 - investigation findings code 3221 removed; 170 added.H6 - investigation conclusions code 4315 removed; 23 added.
Event or Problem Description
It was reported that the 2.75x20 mm nc trek balloon dilatation catheter (bdc) was noted to have ruptured at nominal pressure, as when pressure was increased, the contrast went into the artery.There were no adverse patient effects and there was no clinically significant delay in the procedure.A new similar balloon was used to complete the procedure.Subsequent to the initially filed reports, it was reported that the procedure was to treat the descending coronary artery with no calcification.The shaft/guide wire exit port leaked, there was no rupture.No additional information was provided.

• 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: 17856933
• Report Number: 2024168-2023-10749
• Device Sequence Number: 3278512
• Product Code: LOX
• UDI-Device Identifier: 08717648151835
• UDI-Public: (01)08717648151835(17)260131(10)30207G2
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Followup
• Report Date (Section B): 07/26/2024

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 Expiration Date: 01/31/2026
• Device Model Number: 1012448-20
• Device Catalogue Number: 1012448-20
• Device Lot Number: 30207G2
• 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: 09/12/2023
• Supplement Date Received by Manufacturer: 04/09/2024; 07/15/2024
• Initial Report FDA Received Date: 10/02/2023
• Supplement Report FDA Received Date: 04/23/2024; 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/07/2023
• 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