MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model 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	09/17/2020
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 the patient was diagnosed with pulmonary arterial hypertension in the course of chronic thromboembolism and narrowed pulmonary artery.A 5.0x15mm trek rx balloon dilatation catheter (bdc) was prepared per the instructions for use, and a 50/50 contrast mix was used, however, resistance was felt when removing the protective sheath.The bdc was advanced, and inflated once to 6 atmospheres.An attempt was made to deflate the balloon by pulling a negative for 50-60 seconds a few times, but failed.After several unsuccessful attempts the bdc was removed partially deflated, and resistance with the anatomy was felt.The bdc was removed as a unit with the introducer sheath, guide catheter, and bmw guide wire.The procedure was successfully completed, and the patient is okay.There were no adverse patient effects, and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported deflation problem and the reported difficult to remove - guiding catheter were unable to be replicated in a testing environment due to the condition of the returned device.The reported difficult to remove - anatomy unable to be replicated in a testing environment as it was based on operational circumstances.The reported difficult to remove - protective sheath unable to be replicated in a testing environment as the sheath was not returned for analysis.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 did not indicate a lot specific quality issue.As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported deflation problem, difficult to remove - guiding catheter and difficult to remove ¿ anatomy appear to be related to circumstances of the procedure as it is likely that manipulation of the device and/or interaction with other devices/anatomy resulted in the noted multiple outer member and inner member damages (stretched, collapsed); thereby reducing the inflation/deflation lumen thus resulting in the reported deflation problem, the reported difficult to remove - guiding catheter and the reported difficult to remove ¿ anatomy.The noted multiple bends and kink on the hypotube and the noted hypotube separation likely occurred due to handling or during packing for return analysis.Additionally, it is possible that inadvertent mishandling resulted in the reported difficult to remove - protective sheath; however this cannot be confirmed.The investigation determined a conclusive cause for the reported difficult to remove - protective sheath cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
Additional information: the balloon dilatation catheter was removed with the guide catheter because it was impossible to deflate and remove it from the guiding catheter.No additional information was provided.

• Brand Name: TREK CORONARY DILATATION CATHETER
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10665529
• Report Number: 2024168-2020-08496
• Device Sequence Number: 4283839
• Product Code: LOX
• UDI-Device Identifier: 08717648138782
• UDI-Public: 08717648138782
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2020

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: 03/31/2023
• Device Model Number: 1012280-15
• Device Catalogue Number: 1012280-15
• Device Lot Number: 00402G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Initial Date Received by Manufacturer: 09/21/2020
• Supplement Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 10/12/2020
• Supplement Report FDA Received Date: 12/01/2020
• 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: GUIDE CATHETER: MEDTRONIK LAUNCHER; GUIDE WIRE: BMW; INTRODUCER SHEATH: BALTON 80CM; GUIDE CATHETER: MEDTRONIK LAUNCHER; GUIDE WIRE: BMW; INTRODUCER SHEATH: BALTON 80CM