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

Model Number	1012270-30
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Angina (1710); Non specific EKG/ECG Changes (1817)
Date of Event	11/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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.It was reported that the balloon was not soaked prior to use.It should be noted that the coronary dilatation catheters (cdc), trek rx and mini trek rx, global instructions for use (ifu) preparation for use section states: submerge the balloon in sterile heparinized normal saline during balloon preparation, to activate the coating.In this case, it is unknown if the ifu violation caused or contributed to the reported complaint.The reported patient effect of angina is listed in the coronary dilatation catheters (cdc), trek rx and mini trek rx, global, instructions for use as a known patient effect.The investigation was unable to determine a conclusive cause for the reported leak and inflation issue.However, factors that can contribute to a leak in the system include, but are not limited to, manufacturing, balloon damage during use, inflation technique, interactions with accessory devices, catheter damage, or insufficient preparation prior to use.Subsequently, it is possible that the reported leak contributed to the reported partial inflation of the balloon.The reported additional treatment appears to be related to circumstances of the procedure.A conclusive cause for the reported patient effects of angina and st elevation (ekg/ecg changes) 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.
Event or Problem Description
It was reported that the procedure was to treat a right coronary artery.A 2x30mm mini trek balloon was prepared as usual but not soaked prior to use.The device was advanced to the lesion and when inflated, there was no movement on the manometer but the balloon inflated only a little bit, but was noted as losing pressure.The patient developed chest pain and st-elevation for approximately 5 minutes.The balloon was simply removed and a stent was implanted to successfully treat the chest pain and st elevation.Afterwards when flushing the balloon outside the anatomy, a leakage was noted at the mid shaft.The patient is doing fine.There was no adverse patient sequela and no clinically significant delay.No additional information was provided.

• Brand Name: MINI TREK CORONARY DILATATION CATHETER
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10870042
• Report Number: 2024168-2020-09758
• Device Sequence Number: 14226786
• Product Code: LOX
• UDI-Device Identifier: 08717648138188
• UDI-Public: 08717648138188
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K103110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/19/2020

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: 06/30/2023
• Device Model Number: 1012270-30
• Device Catalogue Number: 1012270-30
• Device Lot Number: 00702G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2020
• Initial Report FDA Received Date: 11/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention