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

Model Number 1012455-12

Device Problems Deflation Problem (1149); Failure to Fold (1255); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/25/2019

Event Type  Injury  

Manufacturer Narrative

Exemption number: e2019001.(b)(4).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 of the reported lot did not indicate a lot specific quality issue.The device was not returned for evaluation.It was reported that the contrast mix used during the procedure was 10 ml of contrast and 15 ml of saline.It should be noted that the coronary dilatation catheters (cdc), nc trek rx, global instructions for use (ifu, materials required section) specified that the contrast is 60% contrast medium diluted 1:1 with normal saline.In this case, since the contrast ratio used was less than the required percentage it is unknown if the ifu violation caused or contributed to the reported complaint.Additionally, it was reported that the nc trek bdc was inflated two times to 20 atmospheres.Per the ifu (warning section) states: balloon pressure should not exceed the rated burst pressure (rbp).The rbp for the nc trek rx device is 18 atm.In this case, it is unknown if the ifu deviation caused or contributed to the reported complaint.The investigation was unable to determine a conclusive cause for the reported deflation issue; however, the reported difficulty removing the device appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

Event Description

It was reported that the procedure was to treat an unspecified coronary artery that did not have any tortuosity or calcification.Post-dilatation was performed with a 4.5 x 12 mm nc trek balloon catheter without any issues.Then, a 5.0 x 12 mm nc trek balloon catheter was used and was inflated two times at 20 atmospheres.There were then issues deflating the balloon as it was partially deflated and could not be removed through the guiding catheter.Therefore, the device and the guiding catheter were both removed as a single unit.It was not possible to use the introducer sheath to remove the device.Additionally, the contrast mix was 10 ml of contrast and 15 ml of saline.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Event Description

Subsequent to the initial 30-day medwatch report, the device was returned for analysis.Additional information indicated that due to balloon refold and difficulty removing the device from the anatomy, the hypotube was cut to facilitate the removal.The balloon did not rupture.No additional information was provided.

Manufacturer Narrative

Visual, dimensional and functional inspections were performed on the returned device.The reported difficulty removing the device from the guiding catheter and failure to fold were confirmed.The reported deflation issue 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 of the reported lot did not indicate a lot specific quality issue.It was reported by the account that the balloon was over inflated two times at 20 atmospheres (atms) and returned device analysis noted a longitudinal rupture on the balloon.Per the instructions for use: balloon pressure should not exceed the rated burst pressure (rbp).The rbp for the nc trek rx device is 18 atm.In this case, it is likely that the over inflation of the balloon resulted in the noted balloon rupture on the returned device.Furthermore, it is likely that since the balloon ruptured, deflation couldn¿t be complete resulting in the balloon failure to fold and subsequently the difficulty removing the device.Additionally, it was reported that the contrast mix used in the during the procedure was 10 ml of contrast and 15 ml of saline.It should be noted that the ifu specifies that the contrast is 60% contrast medium diluted 1:1 with normal saline.In this case, since the contrast ratio used was less than the required percentage it is unknown if the ifu violation caused or contributed to the reported complaint.The investigation determined the reported deflation issue appears to be related to user error as the balloon ruptured due to over inflation.The reported failure to fold and difficulty removing the device 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 the device.H6: method code 4114-removed.Conclusion code - 67-removed.

• 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: 9209754
• MDR Text Key: 174549125
• Report Number: 2024168-2019-12734
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648152146
• UDI-Public: 08717648152146
• 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: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: 1012455-12
• Device Catalogue Number: 1012455-12
• Device Lot Number: 80917G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Date Manufacturer Received: 01/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR
• Patient Weight: 55