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

Model Number	1012452-08
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2019001.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.
Event or Problem Description
It was reported that the procedure was to treat a lesion located in an unspecified coronary artery that was mildly calcified.The nc trek balloon ruptured in the patient at unknown atmosphere.It is not known if the device was soaked prior to use of if air aspiration was performed outside the anatomy.Another balloon was used to complete the procedure.There were no reported patient effects or clinically significant delay.No additional information was provided.
Event or Problem Description
Subsequent to the previously filed report, the correct size of the nc trek balloon is a 3.5 x 8 mm, part number 1012451-08.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported material rupture was unable to be confirmed however there was a noted outer member tear.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 from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that during advancement interaction with the mildly calcified anatomy and/or other devices resulted in the reported material rupture/noted outer member tear.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.D4 correction: part/udi number.

• 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: 9492880
• Report Number: 2024168-2019-14729
• Device Sequence Number: 1410433
• Product Code: LOX
• UDI-Device Identifier: 08717648152016
• UDI-Public: 08717648152016
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K103153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: 1012452-08
• Device Catalogue Number: 1012451-08
• Device Lot Number: 90726G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Initial Date Received by Manufacturer: 11/26/2019
• Supplement Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 12/19/2019
• Supplement Report FDA Received Date: 02/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1