MAUDE Adverse Event Report: AV-TEMECULA-CT TREK CORONARY DILATATION CATHETER

Catalog Number	1012276-30
Health Effect - Clinical Codes	Dyspnea (1816); Foreign Body In Patient (2687)
Date of Event	05/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4 internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.Incorrect anatomy.Evaluation summary: visual inspection was performed on the returned device.The shaft separation was confirmed.It should be noted that the information for use, states: the trek rx coronary dilatation catheters are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion, balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with st-segment elevation myocardial infarction and balloon dilatation of a stent after implantation.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 incidents from this lot.The investigation was unable to determine a conclusive cause for the reported complaint as limited information of the original procedure was reported; however, the reported patient effects of dyspnea, foreign body in patient, additional treatment and hospitalization appear to be related to the reported separation or circumstances of the procedure.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported the patient had a procedure performed on (b)(6) to treat a lesion in a pulmonary vessel with a 3.5 x 30 mm rx trek balloon catheter.The procedure was completed successfully with no consequences noted.However, five months later (b)(6), the patient experienced dyspnea.Time-division multiplexing (tdm) imaging [fluoroscopy] was performed and it was observed that the distal part of the trek balloon catheter had separated and was left in the pulmonary artery at the time of procedure on (b)(6).The separated distal section of the device was retrieved successfully with a lasso technique and no surgery was required.After, the patients condition was fine and no treatment was needed for the dyspnea.No additional information was provided.

• Brand Name: TREK CORONARY DILATATION CATHETER
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6997535
• Report Number: 2024168-2017-08625
• Device Sequence Number: 1050883
• Product Code: LOX
• UDI-Device Identifier: 08717648138607
• UDI-Public: 08717648138607
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K103110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/02/2017

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: 11/30/2017
• Device Catalogue Number: 1012276-30
• Device Lot Number: 41210G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2017
• Initial Report FDA Received Date: 11/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention