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

Model Number	1012453-20
Medical Device Problem Codes	Deflation Problem (1149); Material Rupture (1546)
Health Effect - Clinical Codes	Death (1802); Occlusion (1984); Perforation (2001)
Date of Event	01/23/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.On january 15, 2020, the abbott vascular determined that a field safety corrective action is required for specific lots of nc trek rx coronary dilatation catheter and nc traveler coronary dilatation catheter.The field safety action number is 2024168-1/27/2020-001.This action is being taken as a result of an increase in the complaint trend for reported failures of deflation for nc trek rx and nc traveler rx coronary dilatation catheter.Product from identified lots may exhibit slow, partial or failure to deflate.
Event or Problem Description
It was reported that on (b)(6) 2020, the patient presented with an st elevated myocardial infarction.A percutaneous coronary intervention was initiated on the left anterior descending (lad), moderately calcified lesion.An nc trek (1012453-20, 90923g1) dilatation catheter advanced to the lesion site and inflated without reported issues.Deflation was attempted; however, the balloon was unable to deflate.As troubleshooting, the balloon was re-inflated.The balloon had then ruptured and the lad perforated.A covered stent was implanted as treatment.The diagonal coronary artery then ¿shut down¿.Pericardiocentesis was performed.On (b)(6) 2020, the patient had expired while in critical care.No additional information as provided regarding this issue.
Additional Manufacturer Narrative
The device was not returned for evaluation.A review of the lot history record identified one manufacturing nonconformity issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history of the reported lot revealed one similar complaint from this lot which is associated with an exception.The investigation determined the reported deflation issue is related to a manufacturing issue.A conclusive cause for the reported balloon rupture could not be determined.A conclusive cause for the reported patient effects of death, perforation and occlusion and the relationship to the device, if any, cannot be determined.Furthermore, the additional treatment appears to be related to circumstances of the procedure.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.On january 15, 2020, the abbott vascular determined that a field safety corrective action is required for specific lots of nc trek rx coronary dilatation catheter and nc traveler coronary dilatation catheter.The field safety action number is 2024168-1/27/2020-001.This action is being taken as a result of an increase in the complaint trend for reported failures of deflation for nc trek rx and nc traveler rx coronary dilatation catheter.Product from identified lots may exhibit slow, partial or failure to deflate.
Additional Manufacturer Narrative
The device was not returned for evaluation.A review of the lot history record identified one manufacturing nonconformity issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history of the reported lot revealed one similar complaint from this lot which is associated with an exception.The investigation determined the reported deflation issue is related to a manufacturing issue.A conclusive cause for the reported balloon rupture could not be determined.Additionally, it is most likely that the reported deflation issue contributed to the reported patient effects of perforation, occlusion and death.On (b)(6)2020 , the abbott vascular determined that a field safety corrective action is required for specific lots of nc trek rx coronary dilatation catheter and nc traveler coronary dilatation catheter.The field safety action number is 2024168-1/27/2020-001.This action is being taken as a result of an increase in the complaint trend for reported failures of deflation for nc trek rx and nc traveler rx coronary dilatation catheter.Product from identified lots may exhibit slow, partial or failure to deflate.H10.

• 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: 9727825
• Report Number: 2024168-2020-01609
• Device Sequence Number: 11381394
• Product Code: LOX
• UDI-Device Identifier: 08717648152085
• UDI-Public: 08717648152085
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/29/2020

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: 08/31/2022
• Device Model Number: 1012453-20
• Device Catalogue Number: 1012453-20
• Device Lot Number: 90923G1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/24/2020
• Supplement Date Received by Manufacturer: 04/28/2020; 04/29/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 04/28/2020; 04/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1133-2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 65 YR
• Patient Weight: 100