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

Model Number	1012280-15
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2024
Type of Reportable Event	Serious Injury
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 the procedure was to treat a lesion in the proximal left anterior descending (plad) artery.The hi-torque (ht) pilot 50 guide wire failed to cross due to the anatomy.A 90 degree angled microcatheter was advanced due to the angulation and was then able to advance the same ht pilot 50 guide wire with difficulty into the distal lad (dlad).Aspiration thrombectomy was performed.Then a compliant 2.5mm balloon was used to perform angioplasty to the proximal and distal lad.Distal occlusion was still noted likely due to clot embolization so i went back with penumbra catheter to perform additional aspiration thrombectomy.Then an intravascular ultrasound (ivus) catheter was advanced to the mid lad and ivus was recorded to assess vessel characteristics and reference diameters for stent sizing.Dissection was noted in mid lad.A 4.0x18mm xience skypoint stent was then deployed over the prox-mid lad.The 5.0x15mm trek rx balloon dilatation catheter (bdc) was advanced without resistance and used to post-dilate the stent per standard procedure.After removal of the balloon catheter, the balloon was noted to be dislodged at distal edge of guide catheter due to resistance.Gentle mild force was applied.Due to risk of embolizing the balloon, the guide catheter, wire and balloon were simultaneously removed as a unit.However, the balloon was then stuck at the distal edge of femoral sheath.Another wire was advanced through the guide catheter and a 2.5mm compliant balloon was advanced over wire until it was adjacent to the fractured balloon.The balloon was inflated at low pressure and was able to advance the guide catheter over both balloons and then pull both balloons and guide catheter out simultaneously through the sheath.There was no adverse patient sequelae and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual analysis was performed on the returned device.The reported separation was confirmed.The reported difficulty removing the device from the guiding catheter could not be replicated in a testing environment due to the condition of the returned device.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 removing the device from the guiding catheter is related to a potential product quality issue.Possible factors that can contribute to difficult to remove/resistance with the guiding catheter post-inflation include, but are not limited to, loose balloon folds, guiding catheter lumen obstructions, kinks, bends or procedural technique.Additionally, it should be noted that the coronary dilatation catheters (cdc), trek rx and mini trek rx, global, instruction for use (ifu), states: with 4.5 mm and 5.0 mm balloon dilatation catheters, some increased resistance may be noted upon insertion or withdrawal into or out of the guiding catheter.In this case, a conclusive cause for the reported difficulties could not be determined.Furthermore, the reported separation and unexpected medical intervention appear to be related to operational context.In this case, it is likely that the balloon became separated during manipulation of the device during removal, as difficulty was encountered.Additional treatment was performed to remove the separated portion of the device.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Additional information: a.Patient information was updated.D4 - model # added e4: initial report sent to fda updated from no to yes.G2: report source updated with user facility.Corrections: d1 - brand name updated.D2a - common device name updated.D3 - name updated.D3 - address, city, postal code updated.

• 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: 19440831
• Report Number: 2024168-2024-06470
• Device Sequence Number: 20865339
• Product Code: LOX
• UDI-Device Identifier: 08717648138782
• UDI-Public: (01)08717648138782(17)260531(10)30621G1
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2026
• Device Model Number: 1012280-15
• Device Catalogue Number: 1012280-15
• Device Lot Number: 30621G1
• 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: 05/13/2024
• Supplement Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 05/31/2024
• Supplement Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2023
• 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: 2.5MM COMPLIANT BALLOON; 6 FR EBU 3.5 GUIDE CATHETER; 6 FRENCH JL4 GUIDE CATHETER; RUNTHROUGH GUIDE WIRE; XIENCE SKYPOINT STENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 35 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Hispanic
• Patient Race: White