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

Model Number	1012276-20
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that the 3.5x20 mm trek was inflated one time at nominal pressure in the mid right coronary artery (rca).Negative pressure was held for three seconds and it mostly deflated.Inflation device was returned to neutral and a second attempt to deflate was made; negative pressure was held for at least five seconds and it still only partially deflated.The trek was retracted out of the rca into the aorta without issue.It was thought that perhaps switching out the inflation device would help, so the inflation device was switched out and the trek was inflated to nominal pressure in the aorta.Negative pressure was held for five seconds and it did not deflate at all this time.It was decided to deliberately rupture the trek by inflating it past the rated burst pressure.The trek was ruptured and was removed from the anatomy.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 the 3.5x20 mm trek was inflated one time at nominal pressure in the mid right coronary artery.Negative pressure was held for three seconds and it mostly deflated.Inflation device was returned to neutral and a second attempt to deflate was made; negative pressure was held for at least five seconds and it still only partially deflated.The trek was retracted out of the rca into the aorta without issue.It was thought that perhaps switching out the inflation device would help, so the inflation device was switched out and the trek was inflated to nominal pressure in the aorta.Negative pressure was held for five seconds and it did not deflate at all this time.It was decided to deliberately rupture the trek by inflating it past the rated burst pressure.The trek was ruptured and was removed from the anatomy.There were no adverse patient effects and no clinically significant delay in the procedure.Subsequent to the previously filed report, additional information was received that there was difficulty removing the partially deflated trek balloon from the right coronary artery.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 replicated in a testing environment due to the condition of the returned device.The reported difficulty removing the device could not be replicated in a testing environment as it was based on operational circumstances.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 and/or complaints reported 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.H6 coding: device code 1546 was removed.

• 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: 9622920
• Report Number: 2024168-2020-00862
• Device Sequence Number: 2927820
• Product Code: LOX
• UDI-Device Identifier: 08717648138584
• UDI-Public: 08717648138584
• 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): 04/06/2020

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: 01/31/2022
• Device Model Number: 1012276-20
• Device Catalogue Number: 1012276-20
• Device Lot Number: 90225G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2020
• Initial Date Received by Manufacturer: 01/08/2020
• Supplement Date Received by Manufacturer: 03/18/2020
• Initial Report FDA Received Date: 01/23/2020
• Supplement Report FDA Received Date: 04/06/2020
• 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: Required Intervention
• Patient Age: 50 YR