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

Catalog Number	1012280-15
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number: e2019001.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.The nc trek rx device referenced is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was performed to treat a heavily calcified lesion in the mid right coronary artery.A 5.0x15mm nc trek balloon dilatation catheter (bdc) was being used to post-dilate an unspecified stent; however, the balloon would not deflate.Multiple attempt to deflate the balloon with the indeflator were made and the bdc was even flushed with saline in an attempt to dilute the 50/50 contrast mix but were all unsuccessful.The bdc was removed with the balloon partially inflated.After removal, it was noted that the balloon was partially separated from the shaft although it was still all in one piece.A 5.0x15mm trek rx bdc was advanced and inflated, but the balloon would not deflate.Multiple attempts to deflate the balloon were made with the indeflator and the balloon partially deflated.During removal the bdc could not go through the guiding catheter; therefore, both were removed as a unit.The procedure was successfully completed with no additional intervention.There were no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.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 from this lot.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.It was initially reported that the device would be returned for analysis.Subsequent information revealed that the device was has been retained by the hospital and is not available for evaluation.

• Brand Name: TREK RX CORONARY DILATATION CATHETER
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9210672
• Report Number: 2024168-2019-12746
• Device Sequence Number: 14229992
• Product Code: LOX
• UDI-Device Identifier: 08717648138782
• UDI-Public: 08717648138782
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 11/27/2019

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: 04/30/2022
• Device Catalogue Number: 1012280-15
• Device Lot Number: 90522G1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/27/2019
• Supplement Date Received by Manufacturer: 11/11/2019
• Initial Report FDA Received Date: 10/18/2019
• Supplement Report FDA Received Date: 11/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR