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

Model Number	1012274-15
Medical Device Problem Codes	Leak/Splash (1354); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat the bifurcation of the lcx and lad.The 3x15mm trek balloon dilatation (bdc) advanced to in the lad distal of the target lesion, then the 3.5x23mm xience skypoint stent delivery system (sds) was advanced to the target lesion in the bifurcation; however, resistance was felt and blood was noted to be coming to the inflation device.It was then realized that the sds was advance inadvertently on the same guide wire (gw) as the bdc and the sds was pushed into the bdc causing the balloon of the bdc to become torn.The trek bdc and the xience skypoint sds were removed independently from the patient without issue.Another same size trek bdc and same size xience skypoint sds were used to continue the procedure.There was no adverse patient effect and no clinically significant delay reported in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the production records and the corrective and preventive actions (capa) database was performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed no indication of a lot specific issue.The investigation determined the reported torn balloon appears to be related to the operational context of the procedure.It was reported that the balloon dilation catheter (bdc) interacted with a stent delivery system that was being advanced on the same guide wire.Interaction between the devices resulted in the reported torn balloon; thus resulting in the reported leak.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the production records and the corrective and preventive actions (capa) database was performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed no indication of a lot specific issue.The investigation determined the reported leak appears to be related to the operational context of the procedure.It was reported that the balloon dilation catheter (bdc) interacted with a stent delivery system that was being advanced on the same guide wire.Interaction between the devices likely resulted in damage; thus resulting in the reported leak.There is no indication of a product quality issue with respect to manufacture, design, or labeling.H6 correction: medical device problem code 4008 removed.H11 correction: additional mfg narrative updated to remove reference of torn.
Event or Problem Description
Subsequent to the initial report, additional information reported that the resistance was noted when the xience skypoint sds was being advanced on the same guide wire has the trek bdc.When the sds reached the shaft/hypotube where at the guide wire exit notch the resistance was felt.Several attempts were made to advance the sds, the sds was not able to be advanced to the being on the same guide wire as the bdc.Therefore, the sds was removed and blood was noted to be backing up into the inflation device attached to the balloon.A tear was not noted on the balloon.No additional information was provided.

• Brand Name: 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: 20081840
• Report Number: 2024168-2024-10126
• Device Sequence Number: 7590364
• Product Code: LOX
• UDI-Device Identifier: 08717648138430
• UDI-Public: (01)08717648138430(17)270331(10)40416G1
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K103110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2024

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: 1012274-15
• Device Catalogue Number: 1012274-15
• Device Lot Number: 40416G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2024
• Supplement Date Received by Manufacturer: 09/27/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 3.5X23MM XIENCE SKYPOINT STENT.
• Patient Sex: Male