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

Catalog Number	1012453-15
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the mid left anterior descending (lad) coronary artery with mild calcification and moderate tortuosity.The 4.0x15mm nc trek balloon dilatation catheter (bdc) was being used for post dilatation; however, a rupture occurred on the first inflation at 8 atmospheres.Another non-abbott device 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.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
The device was not returned for evaluation.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 determined the reported complaint 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.D9/h3 - device available for evaluation updated from yes to no.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the mid left anterior descending (lad) coronary artery with mild calcification and moderate tortuosity.The 4.0x15mm nc trek balloon dilatation catheter (bdc) was being used for post dilatation; however, a rupture occurred on the first inflation at 8 atmospheres.Another non-abbott device was used to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.Subsequent to the initially filed reports, the device was received and the returned device analysis identified that parts of the inner/outer member were separated and not returned.Additionally a portion of the proximal balloon marker was possibly missing a portion which was not returned.Therefore, there is the potential the missing pieces not returned remain in the patient.No additional information was provided.
Additional Manufacturer Narrative
Nad9/h3: update to return status from no to yes.Subsequent to filing the initial reports, the device was returned.H6: health effect - clinical code 4582 removed; 2687 added.H6: health effect - health impact code 2199 removed; 4614 added.H6: type of investigation code 4114 removed; 10 added.H6: investigation conclusions code 4307 removed; 4311 added.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported balloon rupture 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 determined the reported balloon rupture, foreign body in patient and serious injury/illness/impairment appear to be related to operational context; however, a conclusive cause for the noted separation of the retuned device could not be determined.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.H10 correction: mfg narrative updated based on the returned device analysis which was inadvertently left off of the supplemental mdr.The g3 date is 02/15/24 which is the date the error was noted.

• Brand Name: NC TREK RX CORONARY DILATATION CATHETER
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR COSTA RICA, REG # 3009564766; 52 calle 3 b31 coyol free zone; el coyol alajuela ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 17436239
• Report Number: 2024168-2023-08315
• Device Sequence Number: 8942059
• Product Code: LOX
• UDI-Device Identifier: 08717648152078
• UDI-Public: 08717648152078
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K103153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/15/2024

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: 05/31/2025
• Device Catalogue Number: 1012453-15
• Device Lot Number: 20607G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/13/2023
• Supplement Date Received by Manufacturer: 11/16/2023; 01/23/2024; 02/15/2024
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 11/29/2023; 02/15/2024; 02/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown