MAUDE Adverse Event Report: ABBOTT VASCULAR MINI TREK RX OTW LIMITED INDICATION; CORONARY DILATATION CATHETER

Model Number	1012402-20A
Medical Device Problem Codes	Inflation Problem (1310); Material Rupture (1546); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported the device is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the moderately calcified, moderately tortuous distal right coronary artery.A 1.5x20mm mini trek ii balloon dilatation catheter (bdc) partially inflated and was losing pressure.The leak was noted in the balloon during inflation.An unspecified 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.
Additional Manufacturer Narrative
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 investigation determined the reported difficulty advancing the device appears to be related to operational context; however, a conclusive cause for the reported balloon rupture and inflation issue could not 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 performed to treat a lesion in the moderately calcified, moderately tortuous distal right coronary artery.A 1.5x20mm mini trek ii balloon dilatation catheter (bdc) partially inflated and was losing pressure.The leak was noted in the balloon during inflation.An unspecified balloon was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.Subsequent to the initially filed report, the following information was received: the 1.5x20mm mini trek ii balloon dilatation catheter (bdc) faced resistance during advancement with the anatomy, and the balloon was inflated once to 8 atmospheres.No additional information was provided.

• Brand Name: MINI TREK RX OTW LIMITED INDICATION
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12481654
• Report Number: 2024168-2021-08214
• Device Sequence Number: 11730877
• Product Code: LOX
• UDI-Device Identifier: 08717648180842
• UDI-Public: 08717648180842
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K110617
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: 1012402-20A
• Device Catalogue Number: 1012402-20A
• Device Lot Number: 90119G1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/26/2021
• Supplement Date Received by Manufacturer: 09/17/2021
• Initial Report FDA Received Date: 09/16/2021
• Supplement Report FDA Received Date: 09/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1