MAUDE Adverse Event Report: ABBOTT VASCULAR TREK RX CORONARY DILATATION CATHETER

Catalog Number	UNK RX TREK
Medical Device Problem Codes	Material Separation (1562); Failure to Advance (2524); Difficult to Advance (2920); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2024
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.Attachment medwatch report #mw5153100.
Event or Problem Description
Medwatch # mw5153100 received which states: balloon broke off during percutaneous coronary intervention with dr (b)(6).Balloon was successfully recovered and removed from body.Following receipt of the medwatch, it was reported that this was a reverse controlled antegrade and retrograde tracking (reverse cart) procedure.A repeated external cap crush was performed with an attempted ¿open sesame¿ technique, with the balloon advanced retrograde to dilate the right posterolateral artery / right posterior descending artery (rpl / rpda), but the trek bdc was unable to reach to target site due to the patient anatomy.The 3.5 x 20 mm trek balloon dilatation catheter (bdc) was advanced to the mid/distal right coronary artery (rca); however, upon withdrawal without resistance, the shaft of the bdc was noted to be broken, with the balloon portion separated and remaining in the proximal rca.A balance middleweight (bmw) guide wire and a non-abbott guide wire were advanced past the balloon and electrocauterization was attempted with a non-abbott device; however, this was unable to deflate the balloon.A non-abbott snare device was advanced and was able to snare the proximal edge of the balloon.The physician was eventually able to get the wire to the mid rca, but due to contrast, fluoroscopy and time constraints, it was elected to stop the procedure.No additional information was provided.
Event or Problem Description
Subsequent to the initially filed report, additional information was provided.The compliant device is the 2.5x 15mm trek balloon dilatation catheter.The trek balloon was not inflated as the device was unable to cross.The distal shaft of the balloon dilatation catheter was noted to be separated and was removed with a snare device.No additional information was provided.
Additional Manufacturer Narrative
Product performance engineering reviewed the incident information; however, the product was not returned to abbott vascular for analysis.The corrective action and preventive action records were reviewed and revealed no indication of a product quality issue.A review of the production records and similar complaint query was not performed because the part/lot numbers were not reported.The investigation determined the reported difficulties and subsequent treatment appear to be related to the operational context of the procedure.In this case, it was reported that the balloon catheter encountered difficulty during advancement due to interaction with the anatomy.Additionally, it is likely that manipulation of the balloon catheter, when resistance was encountered, resulted in damage and contributed to the reported material separation.The separated portion of the wire was removed from the anatomy.There is no indication of a product quality issue with respect to manufacture, design, or labeling; therefore, no product-related corrective action will be implemented in this case.Part/lot# updated to unknown.The udi is not known as the part and lot number were not provided.First, last name, title: updated medical device problem code: (b)(4).

• Brand Name: TREK RX 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: 19234793
• Report Number: 2024168-2024-05421
• Device Sequence Number: 17863089
• Product Code: LOX
• UDI-Device Identifier: 08717648138584
• UDI-Public: (01)08717648138584(17)260131(10)30206G1
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2024

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: 01/31/2026
• Device Catalogue Number: UNK RX TREK
• Device Lot Number: 30206G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2024
• Supplement Date Received by Manufacturer: 05/17/2024
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 05/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2023
• 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: COPILOT; TRAPLINER GUIDE EXTENSION CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White