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

Model Number	1012455-15
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The incident information was reviewed; however, the product was not returned to abbott vascular for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot and relabeled lot that would have contributed to this event.Based on the review of similar incident(s) there is no indication of a lot specific product quality issue.The investigation determined the reported deflation issue and difficulty to remove appear to be related to operational circumstances of the procedure.Based on the reported information, it is likely that manipulation of the device during multiple inflations and deflations, the shaft of the balloon catheter became damaged or stretched restricting the flow of contrast which resulted in the deflation issue and difficulty to remove from the guiding catheter and introducer sheath.Additionally, the treatment (delay in procedure) appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to 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 right coronary artery.A 4.0x28mm xience sierra stent was successfully deployed.A 5.0x15mm nc trek rx balloon dilatation catheter (bdc) was used to post-dilate the stent.The bdc was inflated one time at 12 atmospheres (atms) and two more times at 10 atms.An attempt to deflate the bdc was made; however, the balloon only partially deflated even after five attempts to hold a negative.An indeflator was filled with saline and a negative was pulled but this too failed.The balloon partially deflated and was removed as a unit with the guide wire, guiding catheter, and introducer sheath.The procedure was successfully completed with the stent deployment and post-dilatation with the 5.0x15mm nc trek rx bdc.A clinically significant delay was reported due to additional radiation exposure to the patient and staff.No additional information was provided.

• Brand Name: NC TREK RX
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10489531
• Report Number: 2024168-2020-07366
• Device Sequence Number: 2889084
• Product Code: LOX
• UDI-Device Identifier: 08717648152153
• UDI-Public: 08717648152153
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K103153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/03/2020

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: 03/31/2021
• Device Model Number: 1012455-15
• Device Catalogue Number: 1012455-15
• Device Lot Number: 80427GN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2020
• Initial Report FDA Received Date: 09/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STENT: 4.0X28MM XIENCE SIERRA
• Outcome Attributed to Adverse Event: Other