MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number	1012274-30
Medical Device Problem Codes	Deflation Problem (1149); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2021
Type of Reportable Event	Serious Injury
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 this was a procedure to treat a pulmonary artery.A trek rx 3x30mm balloon delivery catheter (bdc) was advanced to the target lesion.However, the balloon was unable to deflated after inflating to 8-10 atmospheres.The physician decided to insert contrast medium 50/50 in order to rupture the balloon.Once ruptured, the balloon was attempted to be removed in the guide catheter.However, during removal, it was observed 20cm of the distal part of the balloon separated.Since the distal part was already in the guide catheter, it was easily removed.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Event or Problem Description
Subsequent to the previously filed report, the following information was provided: the device completely failed to deflate; therefore, the balloon was intentionally ruptured.No additional information was provided.
Additional Manufacturer Narrative
The device was returned.Visual, functional and scanning electron microscopy (sem) analysis/inspections were performed on the returned device.The reported failure to deflate and separation were confirmed.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 incidents/complaints from this lot.The investigation was unable to determine a conclusive cause for the reported failure to deflate; however, the reported separation appears to be related to circumstances of the procedure.It was reported this was a procedure to treat a pulmonary artery.It should be noted the coronary dilatation catheters (cdc), trek rx and mini trek rx, global, instruction for use (ifu) states: the trek rx coronary dilatation catheters are indicated for: balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion, balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with st-segment elevation myocardial infarction, balloon dilatation of a stent after implantation.In this case, it is unknown if the ifu violation contributed to the reported compliant.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.H6: health effect code 4641 added; medical device problem code 2017 were added; health effect code 2199 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: 12615622
• Report Number: 2024168-2021-09117
• Device Sequence Number: 3191704
• Product Code: LOX
• UDI-Device Identifier: 08717648138461
• UDI-Public: 08717648138461
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 12/22/2021

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: 02/29/2024
• Device Model Number: 1012274-30
• Device Catalogue Number: 1012274-30
• Device Lot Number: 10330G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2021
• Supplement Date Received by Manufacturer: 12/16/2021
• Initial Report FDA Received Date: 10/12/2021
• Supplement Report FDA Received Date: 12/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown