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

Model Number	1012276-20
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 a 3.5x20mm trek balloon dilatation catheter (bdc) was being advanced in an unspecified guiding catheter when the shaft separated.The separated portion was removed along with the guiding catheter.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Event or Problem Description
It was reported that a 3.5x20mm trek balloon dilatation catheter (bdc) was being advanced in an unspecified guiding catheter when the shaft separated.The separated portion was removed along with the guiding catheter.There were no adverse patient effects and no clinically significant delay in the procedure.Subsequent to the initially filed report, the following information was received: the procedure was performed to treat a non-calcified left main ostial, left anterior descending, and circumflex coronary artery.A 3.5x20mm trek balloon dilatation catheter (bdc) was advanced over a non-abbott guide wire without resistance.After inflation, the bdc was removed without resistance, and it was noted that the shaft had separated in the unspecified guiding catheter.The entire system was removed, and no portion of the device remains in the anatomy.An unspecified 4x8mm xience stent was used along with a new guiding catheter and guide wire to successfully complete the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported material separation was able to be confirmed.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.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 after the last inflation, during withdrawal manipulation of the device, interaction with other devices and/or inadvertent mishandling resulted in the noted device damages (multiple stretched outer member, balloon folded in toward itself, mislocated proximal balloon marker) and ultimately resulted in the reported/noted material separations (inner/outer member).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.B3, b6: date of event updated to (b)(6) 2020.

• Brand Name: TREK RX
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10567749
• Report Number: 2024168-2020-07900
• Device Sequence Number: 16935872
• Product Code: LOX
• UDI-Device Identifier: 08717648138584
• UDI-Public: 08717648138584
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K103110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2020

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: 12/31/2022
• Device Model Number: 1012276-20
• Device Catalogue Number: 1012276-20
• Device Lot Number: 00115G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Initial Date Received by Manufacturer: 09/01/2020
• Supplement Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 09/22/2020
• Supplement Report FDA Received Date: 11/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1