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

Model Number	1012274-30
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920); Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2024
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.
Event or Problem Description
It was reported that when the3.0x30 mm trek balloon dilatation catheter (bdc) was being advanced onto the guide wire and resistance was noted.The guide wire was inside the anatomy while the balloon was advanced.The distal shaft of the trek bdc was noted to be broken but remained in one piece.There were no reported adverse patient effects, and there was no reported clinically significant delay in the procedure.An unspecified balloon was used to complete the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual, dimensional, and functional analysis were performed on the returned device.The reported difficulty advancing the device over the guide wire, break or material too soft/flexible (flimsy) could not be confirmed.Production record 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.Based on the reported information and results of the complaint investigation there is no indication the reported difficulty advancing the device over the guide wire, break or material too soft/flexible (flimsy) are related to a potential product quality issue.Possible factors that may contribute to the difficulty positioning the bdc over the guide wire may include, but not limited to, device placement technique, guiding catheter support, inner diameter of guide wire lumen, condition of the guide wire, or damage to the distal shaft of the catheter.Returned device analysis noted multiple kins and bends along the outer member and hypotube which possibly resulted from inadvertent mishandling of the device during preparation; however, this cannot be confirmed.In this case, it is possible that the reported resistance resulted from the noted kinks and bends on the device and subsequently gave the impression of the device feeling flimsy and broken; however, since the reported complaints could not be confirmed during return analysis, a conclusive cause cannot be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that when the 3.0x30 mm trek balloon dilatation catheter (bdc) was being advanced onto the guide wire and resistance was noted.The guide wire was inside the anatomy while the balloon was advanced.The distal shaft of the trek bdc was noted to be broken but remained in one piece.There were no reported adverse patient effects, and there was no reported clinically significant delay in the procedure.An unspecified balloon was used to complete the procedure.Subsequent to the initially filed report, it was reported the shaft felt flimsy during advancement.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: 19864175
• Report Number: 2024168-2024-09006
• Device Sequence Number: 8102659
• Product Code: LOX
• UDI-Device Identifier: 08717648138461
• UDI-Public: (01)08717648138461(17)261130(10)31204G3
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 08/22/2024

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: 1012274-30
• Device Catalogue Number: 1012274-30
• Device Lot Number: 31204G3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/09/2024
• Supplement Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 07/30/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED GUIDE WIRE.
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 118 KG