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

Model Number	1012453-20
Medical Device Problem Codes	Deflation Problem (1149); Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.The additional nc trek device is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the right coronary artery.The 4.00x20mm nc trek balloon dilatation catheter (bdc) was prepped outside the anatomy and the contrast mix ratio was 50/50.The bdc was inflated once to dilate the artery.After inflation, the balloon failed to deflate and could not be retrieved into the guiding catheter and could not advance further in the radial artery.A surgeon was called and a cut down was performed to retrieve the balloon from the radial artery.A second 4.00x20mm nc trek bdc was also prepped outside the anatomy and the contrast mix ratio was 50/50.The bdc was advanced through a 6f guiding catheter through access on the other side via the left radial artery.The bdc was inflated five times at 20 atmospheres.Although negative pressure was held for 15 seconds, the bdc only partially deflated.The bdc was able to be retracted into the guiding catheter and both were removed from the patient anatomy as a single unit.The procedure was successfully completed with the patient in good condition.There were no adverse patient sequela and a procedural delay of three hours occurred due to the surgical intervention for the first trek balloon.No additional information was provided.
Event or Problem Description
Subsequent to the initially filed report: the 4.00x20mm nc trek bdc was cut at the proximal end of the hypotube and hub in order to be able to remove the device from the patient anatomy via a cutdown.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported deflation problem was unable to be replicated in a testing environment due to the condition of the returned device.The reported entrapment of device was unable to be replicated in a testing environment as it was based on operational circumstances.A review of the lot history record identified one manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified two other similar incidents from this lot.One sterile/unused device part 1012453-20/ lot 00121g1 was returned.The balloon was inflated and deflated three times meeting specification.The balloon folded flat all three times.The complaint investigation determined the reported deflation problem is related to a potential manufacturing issue associated with deflation issues.The reported entrapment of device was a direct symptom of the reported deflation issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.

• Brand Name: NC 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: 10373806
• Report Number: 2024168-2020-06573
• Device Sequence Number: 2686899
• Product Code: LOX
• UDI-Device Identifier: 08717648152085
• UDI-Public: 08717648152085
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K103153
• 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,Followup
• Report Date (Section B): 10/12/2020

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: 12/31/2022
• Device Model Number: 1012453-20
• Device Catalogue Number: 1012453-20
• Device Lot Number: 00121G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Initial Date Received by Manufacturer: 07/15/2020
• Supplement Date Received by Manufacturer: 10/08/2020
• Initial Report FDA Received Date: 08/06/2020
• Supplement Report FDA Received Date: 10/12/2020
• 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