MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number	1012272-30
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat an anterior interventricular artery.A 2.5x30mm trek balloon dilatation catheter (bdc) was advanced and dilated the target lesion without issue.The bdc was left in the anatomy when a non-abbott stent was then inserted and placed the stent below the bdc.Once the non-abbott stent reached the target lesion, the stent failed to deploy as it became stuck with the bdc.The stent implant was noted as flared and was decided to simply withdraw the stent device.Another stent was used to successfully complete the procedure.The trek balloon remained in the anatomy while the first non-abbot stent was removed and was used with the second successful stent without issue.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for evaluation.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 and/or complaints from this lot.The investigation was unable to determine a conclusive cause for the reported difficulty to remove.Factors that can contribute to difficult to remove/resistance post-inflation include, but are not limited to, loose balloon folds, challenging anatomy, or procedural technique.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat an anterior interventricular artery.A 2.5x30mm trek balloon dilatation catheter (bdc) was advanced and dilated the target lesion without issue.The bdc was left in the anatomy when a non-abbott stent was then inserted and placed the stent below the bdc.Once the non-abbott stent reached the target lesion, the stent failed to deploy as it became stuck with the bdc.The stent implant was noted as flared and was decided to simply withdraw the stent device.Another stent was used to successfully complete the procedure.The trek balloon remained in the anatomy while the first non-abbot stent was removed and was used with the second successful stent without issue.There were no adverse patient effects and no clinically significant delay in the procedure.Subsequent to the initially filed mdr report, additional information was received: the trek balloon pre-dilated the lesion before the non-abbott stent was advanced, however it is unknown how many inflations were performed and to what atmospheres.The trek balloon was fully deflated before the non-abbott stent was advanced to the lesion.No additional information was provided.

• Brand Name: TREK 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: 15261043
• Report Number: 2024168-2022-08937
• Device Sequence Number: 5811911
• Product Code: LOX
• UDI-Device Identifier: 08717648138324
• UDI-Public: 08717648138324
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2022

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: 01/31/2025
• Device Model Number: 1012272-30
• Device Catalogue Number: 1012272-30
• Device Lot Number: 20216G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2022
• Supplement Date Received by Manufacturer: 08/29/2022
• Initial Report FDA Received Date: 08/19/2022
• Supplement Report FDA Received Date: 09/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2022
• 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
• Patient Sex: Unknown