MAUDE Adverse Event Report: COVIDIEN TRAILBLAZER SUPPORT CATHETER; CATHETER, PERCUTANEOUS

Catalog Number	SC-035-090
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Patient Problem/Medical Problem (2688); No Code Available (3191)
Date of Event	07/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A trailblazer device was used with a 5f non-medtronic sheath and 0.36 guidewire during treatment of a calcified cto (chronic total occlusion-100%) in the patient¿s distal left common iliac artery.A steep bifurcation with moderate tortuosity and calcification are reported.Ifu was followed and the device was prepped without issue.Embolic protection was not used.Pre-dilation was not carried out.It is reported the trailblazer separated leaving only the section with the 3-marker band.A non-medtronic snare device was used to retrieve separated piece.The physician believes the trailblazer was caught on a plaque at the bifurcation.The patient will be brought back at another date to have bypass of the lesion which he was trying to treat endovascularly.Patient is reported to be alive with no injury.
Additional Manufacturer Narrative
Additional information: it was originally reported that a 0.36 guidewire was used.The actual guidewire which was used was a 0.035 stiff angled glide wire product analysis: the trailblazer catheter was received for evaluation.No ancillary devices or procedural reports from the procedure were received.Two photographs of cine images were provided.Cine image one showed the targeted vessel anatomy.A guidewire was seen in the right iliac artery approaching the abdominal aorta.There were no ancillary devices in the left iliac artery.Cine image two showed the targeted vessel anatomy.A guidewire was seen in the right iliac artery.The guidewire entered the abdominal aorta.Two radiopaque markers were observed on the guidewire in the right iliac artery.Two addition radiopaque markers were visible in the right iliac artery and a third radiopaque marker was visible in the left iliac artery.The three radiopaque markers not associated with the guidewire were approximately equal distance from each other.The trailblazer catheter was received in two separate segments.The smallest segment included the three radiopaque marker bands.The returned trailblazer support catheter working length was approximately 93.5cm in length.A series of kinks were noted approximately 75.2cm, 77.5cm, 79.8cm, 81.7cm, and 82.0cm distal of the printed strain relief distal tip.The catheter exhibited a separation approximately 83.3cm distal of the printed strain relief distal tip.The catheter separation occurred directly over the most proximal marker band of the support catheter.The proximal separation face appeared to be laterally compressed.The proximal marker band appeared to be laterally compressed.The middle marker band appeared to be laterally compressed.All components of the catheter were accounted for.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: TRAILBLAZER SUPPORT CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 7713289
• Report Number: 2183870-2018-00390
• Device Sequence Number: 1328925
• Product Code: DQY
• UDI-Device Identifier: 00821684073940
• UDI-Public: 00821684073940
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K092299
• 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,Followup
• Report Date (Section B): 10/04/2018

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: 04/09/2021
• Device Catalogue Number: SC-035-090
• Device Lot Number: A626709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2018
• Initial Date Received by Manufacturer: 07/05/2018
• Supplement Date Received by Manufacturer: 08/01/2018; 08/08/2018
• Initial Report FDA Received Date: 07/24/2018
• Supplement Report FDA Received Date: 08/29/2018; 10/04/2018
• 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