MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number 1012276-20

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/14/2022

Event Type  malfunction  

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 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.

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.

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
• Type of Device: 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
• MDR Text Key: 301581581
• Report Number: 2024168-2022-10557
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648138584
• UDI-Public: 08717648138584
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K103110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 04/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 75 KG