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

Model Number	1012448-15
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The other additional vascular device's referenced and the 4.0x15mm rx nc trek referenced are being filed under a separate medwatch report number.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 performed to treat the left main (lm) to the proximal left anterior artery (plad).A kissing balloon technique was done by inflating a 2.75x15mm rx nc trek balloon dilatation catheter (bdc) in the left circumflex and a 4.0x15mm rx nc trek bdc in the lm ¿ plad.Both balloons were pressurized to 8 atmospheres.Both balloons were deflated multiple times as they deflated slowly.While retrieving the 4.0x15mm nc trek, the balloon got stuck with the newly deployed 3.5x15mm xience sierra stent and broke the stent into two parts.The proximal portion of the separated stent was retrieved with the balloon.A snare device was used to retrieve the distal portion of the stent.During retrieval, the broken stent struts caught and explanted a 2.75x48mm xience xpedition stent that had been implanted on (b)(6) 2019 in the mlad.A new unspecified stent was deployed to cover the entire lad.There was no adverse patient sequela reported.No additional information was provided.
Additional Manufacturer Narrative
Visual, dimensional and functional inspections were performed on the returned device.The reported deflation issue could not be confirmed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other similar incidents/complaints from this lot.The investigation was unable to determine a conclusive cause for the reported deflation issue.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

• 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: 9687810
• Report Number: 2024168-2020-01321
• Device Sequence Number: 19432098
• Product Code: LOX
• UDI-Device Identifier: 08717648151828
• UDI-Public: 08717648151828
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 03/09/2020

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: 1012448-15
• Device Catalogue Number: 1012448-15
• Device Lot Number: 90716G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Initial Date Received by Manufacturer: 01/20/2020
• Supplement Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 02/10/2020
• Supplement Report FDA Received Date: 03/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 4.0X15MM RX NC TREK; GUIDEWIRE - RUNTHROUOGH NS; GUIDEWIRE - ASAHI; GUIDING CATHETER - LAUNCHER