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

Catalog Number	1012455-08
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Pain (1994); Obstruction/Occlusion (2422)
Date of Event	12/14/2023
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 an ulcerative lesion in the proximal segment of the right coronary artery (rca) and occlusion in the middle segment.A non-abbott stent was implanted.The 5.0x8mm nc trek rx balloon dilatation catheter (bdc) was used for post dilatation and shaping, inflated 3 times at 14 atmospheres (atms) and held negative for 4-5 seconds.Multiple attempts were made but the catheter could not be retracted since it failed to deflate and was being withdrawn inflated.The suspended balloon could not burst at 30 atms in the right coronary sinus.A non-abbott guide wire was dragged to the brachial artery and still could not puncture the balloon.At the same time, the balloon shaft was broken and separated into two pieces.The patient complained of right arm pain but no treatment was given.Ten minutes after the balloon blocked the vessel, the balloon shaft stump was squeezed and dragged in vitro before it was removed from the sheath.Brachial arteriography showed no extravasation.After removing the balloon and compression bandaging, the patient was returned to the ward for close observation.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
H6: medical device problem code - incorrect removal and above rbp.The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents and/or complaints from this lot.The reported patient effect of obstruction/occlusion is listed in the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use as a known patient effect.It was reported by the account that the balloon was removed inflated.It should be noted the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use (ifu) states: withdraw the deflated dilatation catheter and guide wire from the guiding catheter through the hemostatic valve.In this case, it is likely that the ifu violation contributed to the reported difficulty removing the device.Additionally, the account stated that the balloon was overinflated to 30 atmospheres (atms) in an attempt to rupture the balloon and remove it, as the deflation issue was noted.It should be noted the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use states: balloon pressure should not exceed the rated burst pressure (rbp).The rbp for the nc trek rx device is 18 atm; therefore, rbp was exceeded.In this case, the reported ifu violation did not cause or contribute to the reported complaint as the balloon did not rupture and was overinflated in an attempt for additional treatment.The investigation was unable to determine a conclusive cause for the reported deflation issue; however, the reported difficulty removing the device, separation and unexpected medical intervention appear to be related to circumstances of the procedure.A conclusive cause for the reported patient effects of pain and obstruction /occlusion and the relationship to the device, if any, cannot be determined.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• Brand Name: NC 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: 18466024
• Report Number: 2024168-2024-00332
• Device Sequence Number: 15251930
• Product Code: LOX
• UDI-Device Identifier: 08717648152139
• UDI-Public: 08717648152139
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K103153
• 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
• Report Date (Section B): 02/05/2024

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: 06/30/2026
• Device Catalogue Number: 1012455-08
• Device Lot Number: 30713G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/16/2024
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 02/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2023
• 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: 4.0X18MM FIREBIRD STENT.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown