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

Model Number 1012455-08

Device Problems Deflation Problem (1149); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/26/2020

Event Type  malfunction  

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that the procedure was performed to treat a 90% stenosed and mildly calcified de novo lesion in the proximal right coronary artery.A 4.0x18mm xience sierra stent was deployed without issues.A 5.0x8mm nc trek rx balloon dilatation catheter (bdc) was inflated once for post-dilatation; however, the balloon failed to deflate even after negative pressure was applied for at least 30 seconds.The bdc was eventually retrieved into the guide catheter with the balloon fully inflated and was removed with force.The procedure was successfully completed.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported difficult to remove was able to be confirmed.The reported deflation problem was unable to be replicated in a testing environment due to the condition of the returned device.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 incidents from this lot.As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that inadvertent mishandling resulted in the noted multiple stretched outer member damages thereby reducing the inflation/deflation lumen; thus resulting in the reported deflation problem and the reported difficult to remove.Manipulation of the device in attempts to remove the device resulted in the noted device damages (folded balloon distal taper, stretched balloon inner member, proximal balloon marker was located at distal end of the proximal balloon seal, outer member tear/hole).The noted multiple bends on the hypotube likely occurred due to handling or during packing for return analysis.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.

• Brand Name: NC TREK CORONARY DILATATION CATHETER
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10857304
• MDR Text Key: 216936752
• Report Number: 2024168-2020-09652
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648152139
• UDI-Public: 08717648152139
• Combination Product (y/n): N
• PMA/PMN Number: K103153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: 1012455-08
• Device Catalogue Number: 1012455-08
• Device Lot Number: 90426G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Date Manufacturer Received: 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE CATHETER: 6FJR4HEARTRAIL; GUIDE WIRE: SION; STENT: 4.0X18MM XIENCE SIERRA