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

Model Number 1012270-15

Device Problems Inflation Problem (1310); Leak/Splash (1354); Material Split, Cut or Torn (4008)

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

Event Date 10/22/2021

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a moderately tortuous, moderately calcified de novo left circumflex artery.A 2x15mm mini trek balloon was advanced to the lesion and inflated multiple times at 12 atmospheres but it did not inflate completely.The device was removed and replaced with a same size mini trek, but the same occurred.Another non-abbott balloon was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.Device analysis noted fluid was observed coming out from a longitudinal tear on the outer member 2.5cm proximal to the proximal seal.

Manufacturer Narrative

Visual, functional and sem inspections/analysis were performed on the returned device which identified a tear and a leak.The reported inflation issue was 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 of the reported lot did not indicate a lot specific quality issue.The balloon was ultimately sent to the scanning electron microscopy (sem) lab for further analysis.The sem report determined the outer member leak may be attributed to mechanical damage to the outer surface.The leak was found proximal to the proximal seal.Damage was documented at the leak edges and proximal to the leak on the od surface.The investigation was unable to determine a conclusive cause for the reported inflation issue.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of this device.The additional mini trek device referenced is being filed under a separate medwatch report number.

• Brand Name: MINI 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: 13079283
• MDR Text Key: 284869744
• Report Number: 2024168-2021-12140
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648138157
• UDI-Public: 08717648138157
• Combination Product (y/n): N
• Reporter Country Code: EG
• 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
• Report Date: 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: 1012270-15
• Device Catalogue Number: 1012270-15
• Device Lot Number: 91113G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2019
• 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: 63 YR
• Patient Sex: Female
• Patient Weight: 94 KG