MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number	1012276-20
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.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 a mildly calcified, mildly tortuous, 95% stenosed lesion in the right coronary artery (rca).A 3.5x20mm trek rx balloon dilatation catheter (bdc) was advanced to the target lesion and performed post-dilatation without issue; however, the balloon did not completely deflate.The bdc was safely captured in the guide catheter for removal, but during removal, the catheter of the bdc separated, with the separated balloon portion remaining in the guide catheter.The guide catheter and the separated segment were removed from the anatomy without issue.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other complaints.Balloon deflation issues can be affected by numerous factors including, but not limited to, balloon damage during processing of the balloon material, the materials, inflation technique, and interactions with other devices, lesion or calcification in the graft, or insufficient preparation prior to use, and saline/contrast incorrect ratio.The investigation could not determine the cause for the reported deflation problem, difficult to remove, and material separation.It may be possible that the catheter was damaged during insertion, or the contrast to saline ratio was incorrect resulting in difficult deflation.The difficulty removing, and material separation were then likely due to deflation problem; however, this cannot be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.D9, h3 - device not available for evaluation.
Additional Manufacturer Narrative
The device was returned for analysis.The deflation problem and difficult to remove could not be confirmed due to the condition of the returned device.The material separation was confirmed.It was noted that the balloon was not separated as reported; however, it was noted that the inner member was compressed and separated and the outer memebers was separated.Additionally, the balloon was noted to be inverted.The investigation determined the cause for the difficulties is due to the circumstances of the procedure.It is likely, that the distal shaft at the proximal balloon seal became damaged (necked) during positioning, the device, the catheter or guide wire was pulled damaging the inner member while under inflation.This would slow deflation.The noted inverted balloon, the compressed and the separated inner member, and the separated outer member are likely symptoms of the removal difficulties.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.D9, h3: device available for evaluation.H6: type of investigation code 4114 - removed.H6: investigation conclusions code 4315 - removed.

• 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: 15584500
• Report Number: 2024168-2022-10557
• Device Sequence Number: 20627840
• Product Code: LOX
• UDI-Device Identifier: 08717648138584
• UDI-Public: 08717648138584
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 04/28/2023

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: 1012276-20
• Device Catalogue Number: 1012276-20
• Device Lot Number: 20211G1
• 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: 09/20/2022
• Supplement Date Received by Manufacturer: 12/22/2022; 04/13/2023
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 12/29/2022; 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2022
• 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 Age: 43 YR
• Patient Sex: Male
• Patient Weight: 75 KG