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

Catalog Number 1012451-15

Device Problems Failure to Fold (1255); Leak/Splash (1354); Difficult to Remove (1528); Material Separation (1562); Difficult to Advance (2920); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number (b)(4) permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.Na.

Event Description

It was reported that the procedure was performed to treat a lesion in the circumflex coronary artery.A 3.5 x 15 mm nc trek balloon dilatation catheter (bdc) was used for post-dilatation of an unspecified drug-eluting stent.The balloon inflated four times up to 16 bar, which is approximately 16 atmospheres.Although no deflation issues were noted, the balloon could not be removed independently of an unspecified 6 french guiding catheter due to a plastic bubble [bunched] on the distal end of the balloon.The bdc was removed along with the other devices.Another unspecified catheter was used to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Event Description

Returned device analysis identified that shaft of the 3.5x15mm nc trek balloon dilatation catheter (bdc) was separated and a shaft tear and leak were noted.Follow up with the account confirmed that the bdc met resistance during advancement with the guiding catheter and the shaft tear and shaft leak were noted during the procedure.The account were unable to confirm the separation occurred post procedure as everything was removed from the anatomy as a single unit.No additional information was provided.

Manufacturer Narrative

Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.Visual and functional inspections were performed on the returned device.The reported tear, leak and hypotube separation were confirmed.The reported bubbling/bunched balloon could not be confirmed.The reported difficulty advancing and removing the device from the guiding catheter could not 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 similar incidents and/or complaints from this lot.The investigation was unable to determine a conclusive cause for the reported bubbling/bunching of the balloon, the reported tear and leak.The investigation determined that the reported hypotube separation, difficulty to advance and remove the device from the guiding catheter appears to be related to operational context.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of this device.

• Brand Name: NC TREK RX
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8853103
• MDR Text Key: 153099518
• Report Number: 2024168-2019-10514
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648151989
• UDI-Public: 08717648151989
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 1012451-15
• Device Lot Number: 90528G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Date Manufacturer Received: 11/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 6F GUIDE CATHETER