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

Catalog Number	1012278-30
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).User facility medwatch report# (b)(4).Evaluation summary: visual inspection was performed on the returned device.The reported separation was confirmed.The reported inflation issue could not be replicated in a testing environment due to the condition of the returned device.It should be noted that the instructions for use (ifu) states: 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, or balloon dilatation of a stent after implantation.In this case, it is unknown if the reported ifu violation caused or contributed to the reported complaint.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 determined the reported shaft separation appears to be related to circumstances of the procedure; however, a conclusive cause could not be determined for the inflation issue.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 that the procedure was to treat a lesion in the moderate to heavily calcified, 80% stenosed tibioperoneal (tp trunk) artery.A 4.00 x 30 mm trek rx balloon dilatation catheter (bdc) was selected for the procedure.The bdc was advanced with no resistance felt to the lesion and the balloon would not inflate.During removal of the bdc from the anatomy only a portion of the shaft came out of the patient.It was observed that the distal portion of the shaft with the balloon had separated from the hypotube portion of the shaft.Several unsuccessful attempts with various methods including balloon entrapment, single loop snare and a tri-loop snare of various sizes were made to retrieve the separated distal portion of the bdc from the anatomy.The patient was sent to surgery to have the separated distal portion with the balloon removed from the anatomy.The patient was taken to the icu post-procedure.On (b)(6) 2018 the patient was taken back to the cath lab where a successful intervention was performed on the right superficial femoral artery (sfa).No additional information 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: 7235360
• Report Number: 2024168-2018-00757
• Device Sequence Number: 111528
• Product Code: LOX
• UDI-Device Identifier: 08717648138744
• UDI-Public: 08717648138744
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/01/2018

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: 03/31/2019
• Device Catalogue Number: 1012278-30
• Device Lot Number: 60430G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2018
• Initial Report FDA Received Date: 02/02/2018
• 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: DIL CATH: 2.0 X 30 MM MONORAIL
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 77 YR